Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Home-use dental cement FDA UDI
- Device Name
- Temporary Cement, 7ml Dual Barrel Syringe w/ Eugenol FDA UDI
- Model / Reference
- 10-928 FDA UDI
- Description
- Temporary Cement, 7ml Dual Barrel Syringe w/ Eugenol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526020183 FDA UDI
- 510(k) Number
- K933543 FDA UDI
- GMDN Term
- Home-use dental cement FDA UDI
Classification
- 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
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
Category: Home-use dental cement
Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use dental cement.
- Refilit — Majestic Drug Co., Inc. · Class II
- DenTemp Custom — Majestic Drug Co., Inc. · Class I
- Dentemp — Doc Brands, Inc. · Class I
- Dentemp — Majestic Drug Co., Inc. · Class II
- Refil-it — Doc Brands, Inc. · Class II
- Scott's Select Temporary Cement NE Jars — PRIME DENTAL
- Recapit — Majestic Drug Co., Inc. · Class II
- Recap-it — Doc Brands, Inc. · Class II
Cleared under the same submission
K933543 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dentonics, Inc.
Sources (1)
- FDA UDI 5f8b56f3-392f-47c2-9c1f-4362da256160 35 fields · synced May 30, 2026