Identity
- Trade Name
- ZERAMEX® FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- ZERAMEX®P Provisorium RN (inkl. Screw) FDA UDI
- Model / Reference
- P36530 FDA UDI
- Description
- ZERAMEX®P Provisorium RN (inkl. Screw) FDA UDI
Identifiers
- Catalog Number
- P36530 FDA UDI
- Primary DI / UDI-DI
- 07640161390331 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 7 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDIHeight — 1 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Zeramex® by CeramTec Schweiz GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K152385 also covers:
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
- ZERAMEX® — CeramTec Schweiz GmbH
K163043 also covers:
- CERALOG PL Implant, Ø 3.8 L 11 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 3.8 L 13 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 4.3 L 11 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 4.3 L 13 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 4.3 L 9 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 5.0 L 11 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 5.0 L 13 — CeramTec Schweiz GmbH
- CERALOG PL Implant, Ø 5.0 L 9 — CeramTec Schweiz GmbH
- CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH
- CERALOG® PL Abutment 15° angled, Ø 4.3 mm, GH 1.0 mm — CeramTec Schweiz GmbH
- CERALOG® PL Abutment 15° angled, Ø 5.0 mm, GH 1.0 mm — CeramTec Schweiz GmbH
- CERALOG® PL Abutment straight Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH
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
- CeramTec Schweiz GmbH
Sources (1)
- FDA UDI ba3f8b9b-5077-4278-bce1-6d2c11f35431 37 fields · synced Jun 8, 2026