Identity
- Trade Name
- Vertex-Dental BV FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D print resin for the manufacturing of dentrue bases FDA UDI
- Model / Reference
- NPROBAPI01000 FDA UDI
- Description
- 3D print resin for the manufacturing of dentrue bases FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719425508573 FDA UDI
- 510(k) Number
- K162572 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Dental appliance fabrication material, resin
Vertex-Dental BV by Vertex-Dental B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
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- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
Cleared under the same submission
K162572 also covers:
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
- Vertex-Dental BV — Vertex-Dental B.V.
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
- Vertex-Dental B.V.
Sources (1)
- FDA UDI e09ddef0-3cac-4fad-a238-ca7c9f9e1859 34 fields · synced Jun 1, 2026