Identity
- Trade Name
- Coltolux FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- LIGHT GUIDE, 8 mm CURVED TIP FDA UDI
- Model / Reference
- C7921 FDA UDI
- Description
- LIGHT GUIDE, 8 mm CURVED TIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661C79210 FDA UDI
- 510(k) Number
- K040551 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Dental/surgical polymerization lamp
Coltolux by Coltene/Whaledent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040551 also covers:
- SOLEIL — BENCO DENTAL SUPPLY CO.
- SOLEIL — BENCO DENTAL SUPPLY CO.
- SOLEIL — BENCO DENTAL SUPPLY CO.
- SOLEIL — BENCO DENTAL SUPPLY CO.
- SOLEIL — BENCO DENTAL SUPPLY CO.
- SOLEIL — BENCO DENTAL SUPPLY CO.
- Coltolux — Coltene/Whaledent Inc.
- Coltolux — Coltene/Whaledent Inc.
- Coltolux — Coltene/Whaledent Inc.
- Coltolux — Coltene/Whaledent Inc.
- Coltolux — Coltene/Whaledent Inc.
- Coltolux — Coltene/Whaledent 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 |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 89a76bef-8bad-4a73-a147-3ec5ae9022cc 36 fields · synced Jun 9, 2026