Identity
- Trade Name
- Nexcomp A3 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. FDA UDI
- Model / Reference
- 9440 FDA UDI
- Description
- Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387894407 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Nexcomp A3 by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Meta Biomed, Inc.
Sources (1)
- FDA UDI d628f1b1-ad7e-4f02-8963-56ade82b0ce5 33 fields · synced Jun 1, 2026