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Bone Level Implant

FDA UDI

Class II (US FDA UDI)

by I3 Implant Llc

Identity

Trade Name
Bone Level Implant FDA UDI
Generic Name
Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Model / Reference
I3122010 FDA UDI

Identifiers

Primary DI / UDI-DI
00810027861146 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw analog, reusable 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental prosthesis/implant abutment screw analog, reusable

Bone Level Implant by I3 Implant Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw analog, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I3 Implant Llc

Sources (1)

  • FDA UDI 2cd1099e-5afb-43ae-839c-7ae9e32ddcde 32 fields · synced May 31, 2026