Impression Coping

FDA UDI

Class II (US FDA UDI)

by Megagen Implant Co. Ltd

Identity

Trade Name: Impression Coping FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer FDA UDI
Model / Reference: IT4516NH FDA UDI
Description: AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer FDA UDI

Identifiers

Catalog Number: IT4516NH FDA UDI
Primary DI / UDI-DI: 08806388223619 FDA UDI
510(k) Number: K123988 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, permanent, preformed

Impression Coping is a permanent intermediate fixture level device intended to provide a secure and stable interface between a dental implant and final prosthesis/restoration. The device features one or more structural component(s) such as abutment, ball, bar, bar overlay, coping, ring, and may be made of various materials including titanium (Ti), plastic, gold alloy.

SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
Diamodent — Diamodent · Class II
Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
GS System — OSSTEM IMPLANT Co., Ltd. · Class II
Temporary Abutment — Cybermed Inc. · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II

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: Megagen Implant Co. Ltd

Sources (1)

FDA UDI cd1b921e-cce5-43a3-984d-413f9f64d057 35 fields · synced Jul 13, 2026

Impression Coping

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)