Zeramex®

FDA UDI

Class II (US FDA UDI)

by CeramTec Schweiz GmbH

Identity

Trade Name: ZERAMEX® FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: ZERAMEX®P Implant Ø3.3x12mm SN (incl. Healing Cap) FDA UDI
Model / Reference: P15512 FDA UDI
Description: ZERAMEX®P Implant Ø3.3x12mm SN (incl. Healing Cap) FDA UDI

Identifiers

Catalog Number: P15512 FDA UDI
Primary DI / UDI-DI: 07640161390133 FDA UDI
510(k) Number: K152385 FDA UDI
K163043 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Dimensions & Sizes

Size: Length — 12 Millimeter FDA UDI
Outer Diameter — 3.3 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Zeramex® by CeramTec Schweiz GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Screw endosteal dental implant, two-piece.

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Cleared under the same submission

K152385 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

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Manufacturer

Manufacturer: CeramTec Schweiz GmbH

Sources (1)

FDA UDI 8abed58d-5cd0-4a05-b644-4ea610673188 37 fields · synced May 29, 2026