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Customized Abutment

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref CIHE045P

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name
Pre-milled Blank EUDAMED
Customized Abutment FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Abutment and Abutment screw EUDAMED
Model / Reference
CIHE045P EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08800055762289 EUDAMEDFDA UDI
Basic UDI-DI
88000557CADCAMAY EUDAMED
510(k) Number
K234112 FDA UDI
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
MRI Safety
MR Conditional FDA UDI

Customized Abutment by ARUM DENTISTRY Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K234112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ARUM DENTISTRY Co., Ltd.

Sources (2)

  • FDA UDI f003ed12-acb5-46a2-85d9-d006159799d9 33 fields · synced Oct 7, 2026
  • EUDAMED 04b2ad1b-ecbf-486a-866b-dab5fd70124e 61 fields · synced Jul 16, 2026