Skip to content

Surgystar G01

by Dmetec.Co., Ltd.

Surgystar G01 is a dental ultrasonic surgical system (FDA Class II; FDA product code DZI, Drill, Bone, Powered) made by Dmetec.Co., Ltd., cleared under FDA 510(k) K113152 on 14 Jun 2012 and listed in FDA GUDID since 31 Dec 2016 (UDI-DI 08809462190005), active as of 23 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 23 Oct 2026

Documents

510(k) K113152

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809462190005 UDI-DI Date31 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113152 Date14 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113152 decided 14 Jun 2012 Active
  • FDA GUDID UDI-DI 08809462190005 listed 31 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113152
  2. Listed FDA GUDID 08809462190005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgystar
Generic name
Dental ultrasonic surgical system
Model / reference
G01
Primary DI / UDI-DI
08809462190005
510(k) Number
FDA product code
DZI
GMDN term
Dental ultrasonic surgical system
Device class
Class II
Regulation number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental ultrasonic surgical system

Other devices from Dmetec.Co., Ltd.

See all devices from Dmetec.Co., Ltd. →

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)