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Zuga IDE-000-000

by Zuga Medical, Inc. 2 variants

Zuga IDE-000-000 is a dental drill bit extension (FDA Class II; FDA product code DZE, Implant, Endosseous, Root-Form) made by Zuga Medical, Inc., cleared under FDA 510(k) K122664 on 30 Apr 2013 and listed in FDA GUDID since 12 Jan 2018 (UDI-DI 00854382006934), 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) K122664

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 Number00854382006934 UDI-DI Date12 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122664 Date30 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122664 decided 30 Apr 2013 Active
  • FDA GUDID UDI-DI 00854382006934 listed 12 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122664
  2. Listed FDA GUDID 00854382006934

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zuga
Generic name
Dental drill bit extension
Model / reference
IDE-000-000
Primary DI / UDI-DI
00854382006934
510(k) Number
FDA product code
DZE
GMDN term
Dental drill bit extension
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental drill bit extension

Cleared under the same submission (K122664)

and 8 more cleared under K122664

Similar devices in this category

Other devices filed under Dental drill bit extension.

Other devices from Zuga Medical, Inc.

See all devices from Zuga Medical, Inc. →

Properties

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