Legacy™ Gold Engaging Abutment

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name: Legacy™ Gold Engaging Abutment FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Model / Reference: 8045-40 FDA UDI

Identifiers

Catalog Number: 8045-40 FDA UDI
Primary DI / UDI-DI: 10841307111023 FDA UDI
510(k) Number: K061319 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

Yes

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, permanent, preformed

The Legacy Gold Engaging Abutment is a prefabricated dental implant suprastructure designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. It features one or more structural components, such as an abutment screw(s), which may be included with devices glued to prostheses or can be replaced during cleaning cycles.

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Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
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EZ Post — Megagen Implant Co. Ltd · Class II

Cleared under the same submission

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: Implant Direct Sybron Manufacturing Llc

Sources (1)

FDA UDI 4a65079e-0795-4719-87c4-2e3366e4b227 36 fields · synced Jul 12, 2026

Legacy™ Gold Engaging Abutment

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)