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BioSonic US100R115M

by Coltene/Whaledent Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD661US100R115M0 UDI-DI Date3 Jun 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
BioSonic
Generic name
Ultrasonic dental scaling/debridement system
Model / reference
US100R115M
Primary DI / UDI-DI
D661US100R115M0
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class II
Regulation number
872.4850
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K983727)

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Serial number

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No
  • Manufacturing date: No