Identity
- Trade Name
- Chromaclone FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- Chromaclone 5-day Bubble Gum Refill Fast Set FDA UDI
- Model / Reference
- 4034 FDA UDI
- Description
- Chromaclone 5-day Bubble Gum Refill Fast Set FDA UDI
Identifiers
- Catalog Number
- 4034 FDA UDI
- Primary DI / UDI-DI
- 00883205107633 FDA UDI
- 510(k) Number
- K102739 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Alginate dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
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: Alginate dental impression material
Chromaclone by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alginate dental impression material.
- Bosworth Supergel — Harry J. Bosworth Co. · Class II
- Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material — Dentsply International · Class II
- Orthoquest — Young Innovations, Inc. · Class II
- MDC Dental — MDC DENTAL · Class II
- KROMOPAN — Lascod Spa · Class II
- Allgilloid Plus™ Chromatic Mint Alginate — ORTHO SPECIALTIES · Class II
- Orthoquest — Young Innovations, Inc. · Class II
- Powder scoop + Water measure Neutral — Cavex Holland B.V. · Class II
Cleared under the same submission
K102739 also covers:
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
- Ultradent Products, Inc.
Sources (1)
- FDA UDI cf591e5c-1940-43ae-a615-41f5cfbc4928 37 fields · synced May 30, 2026