Identity
- Trade Name
- MAARC DENTAL-Calx-O FDA UDI
- Generic Name
- Endodontic temporary cement FDA UDI
- Device Name
- It is a water based white paste consisting of premixed Calcium Hydroxide and Barium Sulphate. Supplied in a multi dose syringe with disposable pre-bent cannulas for dispensing. FDA UDI
- Model / Reference
- 9102/1.5x2 FDA UDI
- Description
- It is a water based white paste consisting of premixed Calcium Hydroxide and Barium Sulphate. Supplied in a multi dose syringe with disposable pre-bent cannulas for dispensing. FDA UDI
Identifiers
- Catalog Number
- 9102/1.5x2 FDA UDI
- Primary DI / UDI-DI
- 08906110440403 FDA UDI
- 510(k) Number
- K240446 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic temporary 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
No
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: Endodontic temporary cement
MAARC DENTAL-Calx-O by Shiva Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic temporary cement.
- Metapex Plus 0.8 — Meta Biomed, Inc. · Class II
- Vitapex — Neodental Chemical Products Co., Ltd. · Class II
- Metapex(1 Syringe) — Meta Biomed, Inc. · Class II
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
- Vivid TempFill LC — PEARSON DENTAL SUPPLIES, INC. · Class II
- Metapex(2 Syringe) — Meta Biomed, Inc. · Class II
- Vivid Root MTA — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vitapex — Neodental Chemical Products Co., Ltd. · 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 -Rootfyx — 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-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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shiva Products
Sources (1)
- FDA UDI d809be52-a059-4524-b3f1-7c4dd6ae9f23 36 fields · synced Jun 8, 2026