AccessGUDID - DEVICE: Calm-it™ Desensitizer (D00261A0041)

GUDID

Device Identifier (DI) Information

Brand Name: Calm-it™ Desensitizer
Version or Model: 61A004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61A004
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261A0041
Issuing Agency: HIBCC
Commercial Distribution End Date: January 15, 2019
Device Count: 40
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Calm-It™ Desensitizer Unit Dose Refill

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	VARNISH, CAVITY

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 40 Unit Doses and 1 Unit Dose Holder

Device Record Status

Public Device Record Key: 681a7a6f-8e92-4378-bd60-094e63c283f4
Public Version Date: December 13, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016