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P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
RC Coping, for bridge on multi-base Abutment, straight, D 6.5mm, Ceramicor®/POM FDA UDI
Model / Reference
Final Copings FDA UDI
Description
RC Coping, for bridge on multi-base Abutment, straight, D 6.5mm, Ceramicor®/POM FDA UDI

Identifiers

Catalog Number
023.4761 FDA UDI
Primary DI / UDI-DI
07630031709912 FDA UDI
510(k) Number
K080239 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 6.5 Millimeter FDA UDI

P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K080239 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann SA

Sources (1)

  • FDA UDI 1f43fd7e-b9b2-4c7e-9aad-0dc5fb555906 39 fields · synced Jun 7, 2026