Identity
- Trade Name
- Refilit FDA UDI
- Generic Name
- Home-use dental cement FDA UDI
- Device Name
- Refilit is a Eugenol free temporary dental cement for replacing lost fillings FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Refilit is a Eugenol free temporary dental cement for replacing lost fillings FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00010705400883 FDA UDI
- 510(k) Number
- K964773 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Home-use dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Category: Home-use dental cement
Refilit by Majestic Drug Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use dental cement.
- Dentemp — Doc Brands, Inc. · Class I
- Refil-it — Doc Brands, Inc. · Class II
- Scott's Select Temporary Cement NE Jars — PRIME DENTAL
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- Recap-it — Doc Brands, Inc. · Class II
Cleared under the same submission
K964773 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
- Majestic Drug Co., Inc.
Sources (1)
- FDA UDI e320cdbc-6fb5-49e8-b4e5-98d4e6a2ce71 36 fields · synced Jun 6, 2026