Identity
- Trade Name
- CEREC Guide FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- CEREC Guide Drill Key Set ST FDA UDI
- Model / Reference
- 6373711 FDA UDI
- Description
- CEREC Guide Drill Key Set ST FDA UDI
Identifiers
- Primary DI / UDI-DI
- E27663737112 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: CAD/CAM software
CEREC Guide by Sirona Dental Systems GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CAD/CAM software.
- DTX Studio™ Lab — Nobel Biocare AG · Class II
- SurgiCase Planner — Materialise NV · Class II
- Mimics — Materialise NV · Class II
- ProPlan CMF — Materialise NV · Class I
- HOFFMANN — Stryker Corp. · Class II
- Mimics Flow — Materialise NV · Class I
- TRUST — Rgorithm Korea · Class II
- Medit Temporaries — Medit Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sirona Dental Systems GmbH
Sources (1)
- FDA UDI 1e69adfb-2d8c-4e6d-aced-d0bef32a5a7e 34 fields · synced Jun 6, 2026