← Back to catalogue

Pre/Koh Bone Profiler

FDA UDI

Class I (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name
PRE/KOH BONE PROFILER FDA UDI
Generic Name
Dental implant/prosthesis surgical procedure kit FDA UDI
Device Name
PRE/KOH BONE PROFILER D.4,25 MM, LARGE FDA UDI
Model / Reference
A-PAD-PS425-L FDA UDI
Description
PRE/KOH BONE PROFILER D.4,25 MM, LARGE FDA UDI

Identifiers

Catalog Number
A-PAD-PS425-L FDA UDI
Primary DI / UDI-DI
D7700872273 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant/prosthesis surgical procedure kit 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

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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant/prosthesis surgical procedure kit

Pre/Koh Bone Profiler by Sweden & Martina Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant/prosthesis surgical procedure kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sweden & Martina Inc

Sources (1)

  • FDA UDI 1edc841b-fe39-4e4d-9b04-473118d03cb2 35 fields · synced May 31, 2026