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SABLE - STAR Type 1600410

by Sable Industries Inc

SABLE - STAR Type 1600410 is a Class I device made by Sable Industries Inc, cleared under FDA 510(k) K083101 on 23 Feb 2009 and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 00841359040121), 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) K083101

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 Number00841359040121 UDI-DI Date28 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK083101 Date23 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083101 decided 23 Feb 2009 Active
  • FDA GUDID UDI-DI 00841359040121 listed 28 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083101
  2. Listed FDA GUDID 00841359040121

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SABLE - STAR Type
Generic name
Dental power tool handpiece motorless component
Model / reference
1600410
Primary DI / UDI-DI
00841359040121
510(k) Number
FDA product code
EFB
GMDN term
Dental power tool handpiece motorless component
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)