Identity
- Trade Name
- RetroMTA(RetroMTA-OrthoMTAII) FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure. FDA UDI
- Model / Reference
- RM08 FDA UDI
- Description
- RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800027200047 FDA UDI
- 510(k) Number
- K132825 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endodontic filling/sealing material
RetroMTA(RetroMTA-OrthoMTAII) by BioMTA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
- ACROSEAL TUBE — SEPTODONT SAS SPECIALITES SEPTODONT · Class II
- Pulp Canal Sealer — Ormco Corporation · Class II
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · Class II
Cleared under the same submission
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
- BioMTA
Sources (1)
- FDA UDI 8fb14e62-d5fa-4ab3-b81f-5ae98be981b8 34 fields · synced May 30, 2026