Identity
- Trade Name
- MAARC DENTAL -Rootfyx FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic. FDA UDI
- Model / Reference
- 9107/0.5x4 FDA UDI
- Description
- Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic. FDA UDI
Identifiers
- Catalog Number
- 9107/0.5x4 FDA UDI
- Primary DI / UDI-DI
- 08906110443039 FDA UDI
- 510(k) Number
- K240446 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Hygroscopic dental cement
MAARC DENTAL -Rootfyx by Shiva Products — 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
- 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
- Komet BioRepair — Angelus Industria de Produtos Odontologicos S A · Class II
Cleared under the same submission
K240446 also covers:
- MAARC DENTAL - Ceraseal-B — Shiva Products
- MAARC DENTAL - MTA Fast Set — Shiva Products
- MAARC DENTAL - Sealmax + — Shiva Products
- MAARC DENTAL-Calahyd-RC — Shiva Products
- MAARC DENTAL-Calcium Hydroxide Powder — Shiva Products
- MAARC DENTAL-Calcium Hydroxide Powder (with Barium Sulphate) — Shiva Products
- MAARC DENTAL-Calx-O — Shiva Products
- MAARC DENTAL-MTA Fast set (unidose kit) — Shiva Products
- MAARC DENTAL-MTA Fast set kit — Shiva Products
- MAARC DENTAL-Sealmax + — Shiva Products
- MAARC DENTAL-Sealmax - R — Shiva Products
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
- Shiva Products
Sources (1)
- FDA UDI 276dc6ac-a8f1-4e15-801d-025b9d833e5c 36 fields · synced May 31, 2026