Identity
- Trade Name
- Sable Seek EUDAMEDFDA UDI
- Generic Name
- Dental caries detector, optical induced fluorescence FDA UDI
- Device Name
- Seek & Sable Seek EUDAMEDSable Seek Kit FDA UDISable Seek Refill FDA UDISable Seek Mini Kit Universal FDA UDI
- Model / Reference
- 233 EUDAMEDFDA UDI234 EUDAMEDFDA UDI1021 EUDAMEDFDA UDI
- Description
- Sable Seek Kit FDA UDISable Seek Refill FDA UDISable Seek Mini Kit Universal FDA UDI
Identifiers
- Catalog Number
- 233 FDA UDI234 FDA UDI1021 FDA UDI
- Primary DI / UDI-DI
- 00883205103390 EUDAMEDFDA UDI00883205103383 EUDAMEDFDA UDI00883205104007 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF012AJ EUDAMED
- FDA Product Code
- LFC FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental caries detector, optical induced fluorescence FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental caries detector, optical induced fluorescence
Sable Seek by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (6)
- FDA UDI 8416e239-8998-4ff6-8a62-3d680bbd0523 36 fields · synced Jul 17, 2026
- FDA UDI f71ecf1a-9424-4ed7-b360-dbd02870342b 36 fields · synced May 30, 2026
- FDA UDI b72ceaaa-b6d1-4c97-a3be-e6cd91373fd2 36 fields · synced May 30, 2026
- EUDAMED d63e8ca1-fdd0-4d77-bd44-76af437c13c3 61 fields · synced Jul 9, 2026
- EUDAMED ef573fc3-b985-4f1d-b056-303a87b6fef4 61 fields · synced Jul 10, 2026
- EUDAMED 5b192dec-e142-4d65-91f4-8824a561fefc 61 fields · synced Jul 17, 2026