Identity
- Trade Name
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- NC Temporary Coping, for Cementable Abutment, D 5mm, PMMA FDA UDI
- Model / Reference
- Temporary Coping FDA UDI
- Description
- NC Temporary Coping, for Cementable Abutment, D 5mm, PMMA FDA UDI
Identifiers
- Catalog Number
- 024.2356 FDA UDI
- Primary DI / UDI-DI
- 07630031710420 FDA UDI
- 510(k) Number
- K080286 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Models / Variants
- Cementable Abuntments FDA UDITemporary Copings FDA UDIProtective Caps 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
A comprehensive 2-3 paragraph SEO description written in clear, natural language.
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
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Cleared under the same submission
K080286 also covers:
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS — Institut Straumann SA
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
- Institut Straumann SA
Sources (1)
- FDA UDI 605f22ac-9a2e-4742-ba06-1064e45d02a2 38 fields · synced Jul 30, 2026