Cementable Abuntments +2 more models

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Device Name: NC Cementable All-In-One Set, for crown, D 3.5mm, AH 4mm, GH 1mm FDA UDI
Model / Reference: Final Abutments FDA UDI
Description: NC Cementable All-In-One Set, for crown, D 3.5mm, AH 4mm, GH 1mm FDA UDI

Identifiers

Catalog Number: 027.4301 FDA UDI
Primary DI / UDI-DI: 07630031713551 FDA UDI
510(k) Number: K080286 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure kit FDA UDI
Models / Variants: Cementable Abuntments FDA UDI
Temporary Copings FDA UDI
Protective 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI

Category: Dental implant suprastructure kit

Cementable Abuntments +2 more models by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure kit.

KLOCKNER — SOADCO, S.L. · Class I
KLOCKNER — SOADCO, S.L. · Class II
ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) — CeramTec Schweiz GmbH · Class II
KLOCKNER — SOADCO, S.L. · Class II
CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
KLOCKNER — SOADCO, S.L. · Class II
Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
KLOCKNER — SOADCO, S.L. · Class II

Cleared under the same submission

K080286 also covers:

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: Institut Straumann SA

Sources (1)

FDA UDI 585178b4-a67f-489d-9746-b1064afb2a01 38 fields · synced May 30, 2026