Identity
- Trade Name
- Top Quality Manufacturing FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- TQMPL Smart-Bioceramic Root Canal Sealer - 4 g - Dual Barrel Syringe - Kit FDA UDI
- Model / Reference
- 12609299 FDA UDI
- Description
- TQMPL Smart-Bioceramic Root Canal Sealer - 4 g - Dual Barrel Syringe - Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- TQ26126092991 FDA UDI
- 510(k) Number
- K113568 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hygroscopic dental cement
Top Quality Manufacturing by Top Quality Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hygroscopic dental cement.
- CeraPutty CP10 — Meta Biomed, Inc. · Class II
- Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe — NUSMILE, LTD
- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
- MTA Flow — ULTRADENT PRODUCTS, INC. · Class II
- MAARC DENTAL -Rootfyx — Shiva Products · Class II
- Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g - SAMPLE — NUSMILE, LTD
- Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g — NUSMILE, LTD
- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
Cleared under the same submission
K113568 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
- Top Quality Manufacturing, Inc.
Sources (1)
- FDA UDI 4474b670-7662-4ee9-9d6a-8a3117543936 35 fields · synced May 30, 2026