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ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw)

FDA UDI

Class II (US FDA UDI)

by CeramTec Schweiz GmbH

Identity

Trade Name
ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) FDA UDI
Generic Name
Dental implant suprastructure kit FDA UDI
Device Name
ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) FDA UDI
Model / Reference
SB15515 FDA UDI
Description
ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) FDA UDI

Identifiers

Catalog Number
SB15515 FDA UDI
Primary DI / UDI-DI
07640161394209 FDA UDI
510(k) Number
K163043 FDA UDI
K180184 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure kit 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure kit

ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) by CeramTec Schweiz GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure kit.

Cleared under the same submission

K163043 also covers:

K180184 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CeramTec Schweiz GmbH

Sources (1)

  • FDA UDI 855cd3c1-834d-4a10-b8ae-17e960b7ebfc 35 fields · synced Jun 1, 2026