American Dental Implant

FDA UDI

Class II (US FDA UDI)

by American Dental Implant Corporation

Identity

Trade Name: American Dental Implant FDA UDI
Generic Name: Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name: 4.5mm Tissue Healing Abutment 5mm Neck FDA UDI
Model / Reference: TH4505 FDA UDI
Description: 4.5mm Tissue Healing Abutment 5mm Neck FDA UDI

Identifiers

Catalog Number: TH4505 FDA UDI
Primary DI / UDI-DI: D896TH45050 FDA UDI
510(k) Number: K080397 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, temporary, preformed, single-use 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-use

American Dental Implant by American Dental Implant Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
Neoss Implant System — Neoss, Ltd. · Class II
Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I

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: American Dental Implant Corporation

Sources (1)

FDA UDI 63ed232c-6ba4-4793-995b-599256eb30db 36 fields · synced May 31, 2026

American Dental Implant

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)