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3i Certain

FDA UDI

Class II (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
3i Certain FDA UDI
Generic Name
Dental prosthesis bite verification device FDA UDI
Device Name
Biomet 3i Certain®-compatible 5.0mm Engaging Verification Cylinder FDA UDI
Model / Reference
8001830 FDA UDI
Description
Biomet 3i Certain®-compatible 5.0mm Engaging Verification Cylinder FDA UDI

Identifiers

Catalog Number
8001830 FDA UDI
Primary DI / UDI-DI
00842092104408 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental prosthesis bite verification device 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental prosthesis bite verification device

3i Certain by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis bite verification device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI 89f1ebce-b673-420f-9d58-eef1113bab1c 35 fields · synced Jun 8, 2026