Dentsply Sirona — Primescan & Primescan 2
Dentsply Sirona is the world's largest manufacturer of professional dental products, and its CEREC chairside dentistry brand traces back to the original 1985 Sirona CAD/CAM system — the first commercially available chairside scanner. This page is a neutral manufacturer profile covering Dentsply Sirona's two current standalone intraoral scanners — Primescan and Primescan 2 — parent company, German manufacturing heritage, FDA 510(k) status, DS Core cloud storage, and the workflow data-sharing partnership with 3Shape TRIOS announced in 2023.
About Dentsply Sirona / CEREC
Dentsply Sirona is a publicly traded global dental conglomerate. Its scanner line traces to Sirona Dental Systems, a German company whose CEREC platform (1985) was the first commercial chairside CAD/CAM system. Sirona scanner R&D and manufacturing remain anchored in Bensheim, Germany. The 2016 merger combined US-based Dentsply (consumables) with Germany-based Sirona (digital equipment) into the company now headquartered in Charlotte, NC.
Product Timeline
- 1985CEREC 1 — Sirona (under Siemens) releases the first commercial chairside CAD/CAM scanner. The CEREC family has been continuously developed since.
- 2016Dentsply + Sirona merger creates Dentsply Sirona, the world's largest dental products company.
- 2019Primescan (original) launched — Dentsply Sirona's first dedicated standalone intraoral scanner, positioned for high-precision impressions across chairside and lab-routed workflows.
- 20233Shape × Dentsply Sirona partnership announced (September 21, 2023) — workflow integration between DS Core and 3Shape Unite, harmonizing scan-to-lab routing between Primescan and TRIOS-based labs.
- 2024–2025Primescan 2 released as the wireless, AI-assisted successor. FDA 510(k)
K250771cleared August 29, 2025.
Current Intraoral Scanner Lineup
Per the scope of this page, we focus on Dentsply Sirona's two currently-positioned standalone intraoral scanners. The older Omnicam (CEREC-integrated) is no longer the lead scanner and is not covered here.
Primescan 2
Flagship · Wireless · Cloud-native
Dentsply Sirona's current flagship — a wireless intraoral scanner with AI-assisted scanning, designed to operate fully through the DS Core cloud platform. FDA-cleared in 2025 under K250771.
Primescan
Wired flagship · Still actively sold
The original 2019 Primescan — a wired standalone scanner that established Dentsply Sirona's modern IOS position. Praised by Dentsply Sirona for "Smart Pixel" sensor technology and high-precision data capture. Still actively sold alongside Primescan 2.
Product imagery: Dentsply Sirona / CEREC. Reproduced here for reference; please contact Dentsply Sirona for licensing inquiries.
Workflow Data Sharing with 3Shape TRIOS
On September 21, 2023, Dentsply Sirona and 3Shape jointly announced an expanded workflow-integration partnership covering scan-to-lab routing between their respective cloud platforms. Per the joint announcement:
"Dentsply Sirona and 3Shape are expanding their workflow integrations to enable dental professionals through DS Core and 3Shape Unite to use a scan-to-lab workflow or establish design and manufacturing protocols directly in their practice. The harmonization of DS Core, Primemill and Primeprint, with the 3Shape TRIOS [scanners]…"
What this means practically for a 3DL doctor:
- A practice using Primescan / Primescan 2 → DS Core can send cases to a lab whose pipeline is built around 3Shape Dental System / Unite — and vice versa — without the lab having to re-import scans through a third-party converter.
- The interoperability covers scan exchange (the underlying STL/3D model data), not the proprietary CEREC chairside design files. Cases that are fully designed and milled chairside in CEREC do not need this bridge; cases routed to an external lab do.
- This is an ongoing partnership announcement rather than a one-time release, so specific feature availability evolves — confirm with your DS Core / 3Shape Unite accounts before relying on a particular integration for production cases.
Source: 3Shape Press Newsroom — "Digital Dentistry: Dentsply Sirona and 3Shape expand their workflow integrations" (Charlotte / Copenhagen, September 21, 2023). Verified 2026-05-12.
What Dentsply Sirona Claims as Competitive Advantages
The following are Dentsply Sirona's own published positioning points for Primescan / Primescan 2. We list them as Dentsply Sirona presents them — 3DL has not independently benchmarked these claims.
- 40-year CAD/CAM heritage. Dentsply Sirona positions itself as the originator of chairside CAD/CAM (CEREC, 1985) and frames every Primescan release as built on that lineage.
- Smart Pixel Sensor (Primescan). Per Dentsply Sirona, the Primescan capture sensor processes more than 1,000,000 3D points per second for high-precision data acquisition.
- Wireless flagship (Primescan 2). Primescan 2 is Dentsply Sirona's first fully wireless intraoral scanner — positioned as enabling room-to-room mobility.
- Cloud-native workflow (Primescan 2 + DS Core). Dentsply Sirona positions Primescan 2 as the first IOS fully designed around the DS Core cloud platform, with scans accessible across devices without local install requirements.
- AI-assisted scanning (Primescan 2). AI-assisted features for scan completion guidance, soft-tissue isolation, and quality checks during capture.
- End-to-end chairside option (CEREC). Unique to Dentsply Sirona: a fully integrated single-visit chairside workflow combining Primescan → CEREC software → Primemill (milling) → Primeprint (3D print). Other scanner brands require third-party milling/printing hardware.
- Interoperability with 3Shape. Per the 2023 joint announcement, Primescan scans route to 3Shape Unite-based labs and vice versa — Dentsply Sirona positions this as removing the historical "you use Primescan, you must mill chairside" trade-off.
Claims sourced from Dentsply Sirona product pages, press releases, and the 3Shape joint announcement linked above.
FDA & Regulatory Status
Primescan-family scanners are regulated by the U.S. Food & Drug Administration as Class II medical devices. The most recent 510(k) clearance visible in the openFDA database for a Dentsply Sirona intraoral scanner is below.
| 510(k) Number | Device | Type | Cleared | Applicant |
|---|---|---|---|---|
K250771 | Primescan 2 | Intraoral scanner (NTK product code — laser caries detection feature) | Aug 29, 2025 | Dentsply Sirona, Inc. |
The original 2019 Primescan was cleared under an earlier 510(k) that did not surface under Dentsply Sirona's current "NBL" / "NTK" applicant searches in our verification pass — it may be on file under a Sirona Dental Systems legacy entity name. U.S. clinicians can verify the current 510(k) status of any specific Primescan configuration directly in the FDA's public 510(k) database before purchase.
Cloud Storage & Data Residency (DS Core)
Primescan 2 is designed cloud-first around the DS Core platform — Dentsply Sirona's unified cloud workspace for scans, case routing, and lab connections. Primescan (original) can also push to DS Core, but it predates the cloud-native architecture.
Where Patient Data is Stored
Dentsply Sirona's published Privacy Notice acknowledges international data transfer and identifies the following legal mechanisms for cross-border transfers:
- European Commission-approved Standard Contractual Clauses (SCCs) for transfers out of the EEA.
- UK International Data Transfer Addendum for UK-origin data.
- Region-specific privacy disclosures published for: EMEA (EEA / UK / Switzerland), United States (including California), Canada, Latin America, and APAC.
Dentsply Sirona's public Privacy Notice does not publish a region-by-region cloud sub-processor or data-center table (the way 3Shape does). Practices with strict data-residency requirements for DS Core should request a written sub-processor / region disclosure from Dentsply Sirona before signing.
Compliance Status
- GDPR — applies via Dentsply Sirona's EMEA operations; SCCs used for transfers from the EEA.
- US state privacy laws — Dentsply Sirona's Privacy Notice covers California (CCPA/CPRA) explicitly with a dedicated section.
- HIPAA — Dentsply Sirona publishes a HIPAA Notice of Privacy Practices for its Wellspect subsidiary, but the DS Core cloud Privacy Notice does not explicitly publish a HIPAA Business Associate Agreement (BAA). Practices needing a BAA covering DS Core for PHI storage should request one from Dentsply Sirona directly before storing identifiable patient information.
Working With 3DL on a Primescan / CEREC Workflow
3DL accepts Primescan scans through three routes:
- Direct via DS Core. Connect 3DL as a Lab Partner in your DS Core account; scans flow to our queue automatically. Thanks to the DS Core ↔ 3Shape Unite integration, our 3Shape-based design pipeline ingests Primescan scans natively — no third-party converter step.
- STL / DCM upload through the doctor portal at 3dlmi.com — works with any export from Primescan or the CEREC SW.
- CEREC chairside crowns are designed and milled in your office. For multi-unit, implant, or aesthetic cases where you'd rather hand off to a lab — even off the same Primescan scan — call us.
If you are evaluating a Primescan / Primescan 2 purchase and want to talk about scanner-to-lab fit, call (248) 919-7929.
Send Your First Primescan Case
Open a free account, connect DS Core, and submit a scan — your first single-unit crown is on us.