AccessGUDID - DEVICE: RINN® (D0035525711)

GUDID

Device Identifier (DI) Information

Brand Name: RINN®
Version or Model: 552571
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dentsply International Inc.

Primary DI Number: D0035525711
Issuing Agency: HIBCC
Commercial Distribution End Date: January 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: XCP-ORA® Dexis Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Dexis 4 Horizontal Bitewings with Biteblocks, 4 Vertical Bitewings with Biteblocks. XCP-DS® Dexis 4 Posterior Biteblocks, 4 Anterior Biteblocks. 50 Bulk Sensor Covers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGZ	Holder, film, x-ray
EHA	Aligner, beam, x-ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 070c19a5-fe4b-43b5-8be3-a335231c8803
Public Version Date: March 26, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016