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Xios 6149004

by Sirona Dental, Inc.

Xios 6149004 is a Class II device made by Sirona Dental, Inc., cleared under FDA 510(k) K132953 on 18 Feb 2014 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI D76461490041), 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) K132953

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 NumberD76461490041 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132953 Date18 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132953 decided 18 Feb 2014 Active
  • FDA GUDID UDI-DI D76461490041 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132953
  2. Listed FDA GUDID D76461490041

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xios
Generic name
Instrument/equipment drape, single-use, non-sterile
Model / reference
6149004
Description
SIRONA XIOS+ SENSOR SHEATH SIZE 2 UNIVERSAL SHEATHS SIZE 1 (300/PKG)
Primary DI / UDI-DI
D76461490041
510(k) Number
FDA product code
PEM
GMDN term
Instrument/equipment drape, single-use, non-sterile
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K132953)

and 7 more cleared under K132953

Similar devices

Other devices filed under FDA product code PEM (Dental Barriers And Sleeves).

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)