Identity
- Trade Name
- Promolux High Impact FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Promolux High Impact Polymer, pink, 100g FDA UDI
- Model / Reference
- Promolux High Impact Polymer, pink, 100g FDA UDI
- Description
- Promolux High Impact Polymer, pink, 100g FDA UDI
Identifiers
- Catalog Number
- 1020063 FDA UDI
- Primary DI / UDI-DI
- D7091020063 FDA UDI
- 510(k) Number
- K130076 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
No
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
Dimensions & Sizes
- Size
- Weight — 100 Gram FDA UDI
Category: Dental appliance fabrication material, resin
Promolux High Impact by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
- O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
- Axcent Acrylics — GARRECO, LLC · Class II
- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
- vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
Cleared under the same submission
K130076 also covers:
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
- PremEco Line Prothetik Color System — Merz Dental GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merz Dental GmbH
Sources (1)
- FDA UDI 614b8f37-fab8-4fb4-9dc1-49e1576aa559 37 fields · synced Jun 8, 2026