Microprime 90-00250
by Zest Anchors, LLC EUDAMEDGUDID
Active
Ref 90-00250
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number081659402D0473G | Date29 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00840481135293 | Date10 Mar 2026 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Microprime
- Generic Name
- Dental coating, tooth-desensitizing, professional
- Device Name
- Microprime G - Gel
- Model / Reference
- 90-00250
- Primary DI / UDI-DI
- 00840481135293
- Basic UDI-DI
- 081659402D0473G
- FDA Product Code
- KLE
- EMDN Code
- Q019008 Dentinal desensitisers
- GMDN Term
- Dental coating, tooth-desensitizing, professional
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.3200
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
| Implantable | Yes | No |
Other devices from Zest Anchors, LLC
Properties
Other properties (20)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No