Identity
- Trade Name
- Hygenic FDA UDI
- Generic Name
- Dental cavity liner FDA UDI
- Device Name
- Calcium Hydroxide Points #40 FDA UDI
- Model / Reference
- H01510 FDA UDI
- Description
- Calcium Hydroxide Points #40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H015101 FDA UDI
- 510(k) Number
- K973539 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Dental cavity liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 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
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
No
FDA UDI
Category: Dental cavity liner
Hygenic by Coltene/Whaledent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cavity liner.
- LINING CEMENT — Gc America Inc. · Class II
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- LINING CEMENT — Gc America Inc. · Class II
- GC Fuji LINING™ — Gc America Inc. · Class II
- Cavitec — KERR CORPORATION · Class II
- GC Fuji LINING™ — Gc America Inc. · Class II
- GC Fuji LINING™ — Gc America Inc. · Class II
- LINING CEMENT — Gc America Inc. · Class II
Cleared under the same submission
K973539 also covers:
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
- Hygenic — Coltene/Whaledent Inc.
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
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 199d428e-8307-4e5a-ac67-0f5c1d5bcfa0 36 fields · synced Jun 9, 2026