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CAMLOG® Esthomic® Abutment

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref K2227.3830

by ALTATEC GmbH

Identity

Trade Name
CAMLOG® Esthomic® Abutment EUDAMED
CAMLOG® Esthomic® abutment FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
CAMLOG® Standard abutment EUDAMED
K2227.3830 CAMLOG® Esthomic® abutment, 15deg angled,, type A, d 3.8, GH 3.0-4.5 mm FDA UDI
Model / Reference
K2227.3830 EUDAMEDFDA UDI
Description
K2227.3830 CAMLOG® Esthomic® abutment, 15deg angled,, type A, d 3.8, GH 3.0-4.5 mm FDA UDI

Identifiers

Catalog Number
K2227.3830 FDA UDI
Primary DI / UDI-DI
04099797006483 EUDAMED
E219K222738301 FDA UDI
Basic UDI-DI
40997970001107000000000ES EUDAMED
Secondary DI
E219K222738301 EUDAMED
FDA Product Code
NHA FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

CAMLOG® Esthomic® Abutment by ALTATEC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ALTATEC GmbH
EUDAMED SRN
DE-MF-000006230

Sources (2)

  • EUDAMED 9538c2c9-203c-49a1-b9f1-59fdc0b91826 61 fields · synced Jul 10, 2026
  • FDA UDI d094e8c0-c0b3-4857-825f-5d4554f3008f 35 fields · synced May 30, 2026