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Wide Platform Positioner (2 Units)

FDA UDI

Class I (US FDA UDI)

by Biotechnology Institute Sl

Identity

Trade Name
WIDE PLATFORM POSITIONER (2 UNITS) FDA UDI
Generic Name
Dental implantation depth/angle gauge, reusable FDA UDI
Model / Reference
CPA FDA UDI

Identifiers

Primary DI / UDI-DI
08435389802518 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implantation depth/angle gauge, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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 implantation depth/angle gauge, reusable

The Wide Platform Positioner (2 Units) is a dental implantation depth/angle gauge designed to measure and determine various lengths, including drill depths of the osteotomy cavity, mucosal heights, distances between implants/teeth for mesiodistal position determination, and angles. This reusable device is typically used during the planning stages before surgical implant placement/fixation.

Similar devices

Also classified as Dental implantation depth/angle gauge, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotechnology Institute Sl

Sources (1)

  • FDA UDI 1e4762d5-9d62-4898-b9bf-57641bcf3aaa 32 fields · synced Oct 7, 2026