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Wk-99 Lt S

FDA UDI

Class I (US FDA UDI)

by W & H Dentalwerk Bürmoos GmbH

Identity

Trade Name
WK-99 LT S FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name
Synea Vision Highspeed Handpiece 1:5 FDA UDI
Model / Reference
30215000 FDA UDI
Description
Synea Vision Highspeed Handpiece 1:5 FDA UDI

Identifiers

Primary DI / UDI-DI
J021302150001 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, electric FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical power tool motorized handpiece/set, electric

Wk-99 Lt S by W & H Dentalwerk Bürmoos GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, electric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W & H Dentalwerk Bürmoos GmbH

Sources (1)

  • FDA UDI 5a90af10-49e4-432d-b455-45e64e16546c 33 fields · synced May 31, 2026