← Back to catalogue

TG-98 LW Synea Fusion

FDA UDI

Class I (US FDA UDI)

by W & H Dentalwerk Bürmoos GmbH

Identity

Trade Name
TG-98 LW Synea Fusion FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
Synea Fusion High Speed Handpiece FDA UDI
Model / Reference
30202001 FDA UDI
Description
Synea Fusion High Speed Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
J021302020011 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic 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, pneumatic

TG-98 LW Synea Fusion 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, pneumatic.

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
W & H Dentalwerk Bürmoos GmbH

Sources (1)

  • FDA UDI 34e48c05-d9bc-4212-893e-ed88e2302e1a 33 fields · synced May 30, 2026