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Dento-Surg DEN90110

by Cynosure, LLC

Dento-Surg DEN90110 is a Class II device made by Cynosure, LLC, cleared under FDA 510(k) K955176 on 15 Apr 1996 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00841494102517), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K955176

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841494102517 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955176 Date15 Apr 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955176 decided 15 Apr 1996 Active
  • FDA GUDID UDI-DI 00841494102517 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K955176
  2. Listed FDA GUDID 00841494102517

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dento-Surg
Generic name
Electrosurgical system generator
Model / Ref / Catalog
DEN90110
Primary DI / UDI-DI
00841494102517
510(k) Number
FDA product code
EKZ
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
872.4920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical system generator

Other devices from Cynosure, LLC

See all devices from Cynosure, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)