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Legacy™2 Implant

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name
Legacy™2 Implant FDA UDI
Generic Name
Dental implant system FDA UDI
Device Name
Ø4.7 x 10 Platform 4.5mmD FDA UDI
Model / Reference
834710 FDA UDI
Description
Ø4.7 x 10 Platform 4.5mmD FDA UDI

Identifiers

Catalog Number
834710 FDA UDI
Primary DI / UDI-DI
10841307101772 FDA UDI
510(k) Number
K192221 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental implant system

Legacy™2 Implant by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

Cleared under the same submission

K192221 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implant Direct Sybron Manufacturing Llc

Sources (1)

  • FDA UDI 7dd4a6dd-6a38-4456-9ca9-758d6003574a 37 fields · synced May 31, 2026