← Back to catalogue

BioSonic

FDA UDI

Class II (US FDA UDI)

by Coltene/Whaledent Inc.

Identity

Trade Name
BioSonic FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system FDA UDI
Device Name
Suvi Scaler Tip - PE40 FDA UDI
Model / Reference
60014281 FDA UDI
Description
Suvi Scaler Tip - PE40 FDA UDI

Identifiers

Primary DI / UDI-DI
D661600142810 FDA UDI
510(k) Number
K130137 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
Commercial Distribution
Not 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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

BioSonic by Coltene/Whaledent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130137 also covers:

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
Coltene/Whaledent Inc.

Sources (1)

  • FDA UDI 833b414c-a8df-49f5-9a8b-34564f45859a 36 fields · synced Jun 9, 2026