AccessGUDID - DEVICE: Preference Soft Denture Liner (D040200118701)

GUDID

Device Identifier (DI) Information

Brand Name: Preference Soft Denture Liner
Version or Model: Primer-15ml
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20011870
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040200118701
Issuing Agency: HIBCC
Commercial Distribution End Date: June 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.

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?
17610	Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	Resin, Denture, Relining, Repairing, Rebasing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140146	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 15 ml

Device Record Status

Public Device Record Key: 1b739c17-420b-4bbe-9b2f-4163bf397e84
Public Version Date: July 31, 2019
Public Version Number: 4
DI Record Publish Date: September 02, 2016