Identity
- Trade Name
- PremEco Line Prothetik Color System FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- PremEco Line Prothetik Color System Refill: colour topaz 8g FDA UDI
- Model / Reference
- Refill: colour topaz 8g FDA UDI
- Description
- PremEco Line Prothetik Color System Refill: colour topaz 8g FDA UDI
Identifiers
- Catalog Number
- 1030011 FDA UDI
- Primary DI / UDI-DI
- D7091030011 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 — 8 Gram FDA UDI
Category: Dental appliance fabrication material, resin
PremEco Line Prothetik Color System by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, resin.
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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 24766c0c-3935-4049-b2e8-7f54df1debcf 37 fields · synced May 30, 2026