Identity
- Trade Name
- Darby Dental Supply, LLC FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- COMPOLITE COMPOSITE REGULAR KIT FDA UDI
- Model / Reference
- 9509042 FDA UDI
- Description
- COMPOLITE COMPOSITE REGULAR KIT FDA UDI
Identifiers
- Catalog Number
- 9509042 FDA UDI
- Primary DI / UDI-DI
- 00889813002926 FDA UDI
- 510(k) Number
- K904812 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
Yes
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 — 28 Gram FDA UDI
Category: Dental composite resin
Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K904812 also covers:
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
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
- Darby Dental Supply, Llc
Sources (1)
- FDA UDI 5b4bd020-af90-4568-bdbd-a90ca67fb5b8 37 fields · synced Jun 1, 2026