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Schick B1070008

by Sirona Dental, Inc.

Schick B1070008 is a Class I device made by Sirona Dental, Inc., cleared under FDA 510(k) K963664 on 24 Oct 1996 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI D764B10700080), 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) K963664

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 NumberD764B10700080 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK963664 Date24 Oct 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K963664 decided 24 Oct 1996 Active
  • FDA GUDID UDI-DI D764B10700080 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K963664
  2. Listed FDA GUDID D764B10700080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Schick
Generic name
Instrument/equipment drape, single-use, non-sterile
Model / reference
B1070008
Description
UNIVERSAL SHEATHS SIZE 1 (300/PKG) UNIVERSAL SHEATHS SIZE 1 (300/PKG)
Primary DI / UDI-DI
D764B10700080
510(k) Number
FDA product code
EFB
GMDN term
Instrument/equipment drape, single-use, non-sterile
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Instrument/equipment drape, single-use, non-sterile

Cleared under the same submission (K963664)

and 8 more cleared under K963664

Similar devices

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

Other devices from Sirona Dental, Inc.

See all devices from Sirona Dental, Inc. →

Properties

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