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Implant

FDA UDI

Class II (US FDA UDI)

by Bicon, Llc

Identity

Trade Name
Implant FDA UDI
Generic Name
Basket endosteal dental implant, one-piece FDA UDI
Device Name
2.5 x 10mm Orthodontic Implant FDA UDI
Model / Reference
260-425-210 FDA UDI
Description
2.5 x 10mm Orthodontic Implant FDA UDI

Identifiers

Catalog Number
260-425-210 FDA UDI
Primary DI / UDI-DI
00813110023377 FDA UDI
510(k) Number
K853788 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Basket endosteal dental implant, one-piece 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basket endosteal dental implant, one-piece

Implant by Bicon, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basket endosteal dental implant, one-piece.

Cleared under the same submission

K853788 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bicon, Llc

Sources (1)

  • FDA UDI 08aab0af-4839-40ca-a4da-10f03a02e472 36 fields · synced May 30, 2026