Identity
- Trade Name
- MAARC DENTAL-Calcium Hydroxide Powder FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Calcium hydroxide is used as an agent to induce apexification in pediatric endodontics. The product may also be used as a pulp capping material and as a base under nonadhesive restorations. FDA UDI
- Model / Reference
- 5002/100B FDA UDI
- Description
- Calcium hydroxide is used as an agent to induce apexification in pediatric endodontics. The product may also be used as a pulp capping material and as a base under nonadhesive restorations. FDA UDI
Identifiers
- Catalog Number
- 5002/100B FDA UDI
- Primary DI / UDI-DI
- 08906110440397 FDA UDI
- 510(k) Number
- K240446 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Calcium hydroxide 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
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: Calcium hydroxide dental cement
MAARC DENTAL-Calcium Hydroxide Powder by Shiva Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shiva Products
Sources (1)
- FDA UDI 0c77dff6-a357-4a0e-8bc2-7dfb6539409d 36 fields · synced Jun 8, 2026