DEVICE: XIOS (D76461765511)

Device Identifier (DI) Information

XIOS
6176551
In Commercial Distribution

SIRONA DENTAL, INC.
D76461765511
HIBCC

10
078613913 *Terms of Use
SIRONA ENDO HLDRR ASSY KIT
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental x-ray film holder A device used during the taking of a dental x-ray and that is intended to allow insertion, positioning, stabilization, and removal of x-ray film used in either extraoral or intraoral dental imaging procedures. It holds the film whilst the x-ray is being taken. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EAP Unit, X-Ray, Intraoral
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K933455 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5ced8643-6748-4af6-9349-4be1e25e7b1f
July 06, 2018
3
September 09, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D764B10730760 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
(877) 724-4254
customerserviceny@sirona.com
CLOSE