AccessGUDID - DEVICE: ProTech Soft Reline (D814SRH12C1)

GUDID

Device Identifier (DI) Information

Brand Name: ProTech Soft Reline
Version or Model: SRH12C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRH12C
Company Name: PROTECH PROFESSIONAL PRODUCTS INC

Primary DI Number: D814SRH12C1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117374900 *Terms of Use

Device Description: 16 unit ProTech Soft Reline Heat Cure Kit Shade Clear - 220 gram powder, 120 ml monomer and 15 ml superbond

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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Denture reliner, elastic, short-term	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a coating or lining on the base or tissue-contacting surface of a denture and which has elastic properties after setting and is intended for short-term use. 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.

GMDN Preferred Term Name

GMDN Definition

Denture reliner, elastic, short-term

A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a coating or lining on the base or tissue-contacting surface of a denture and which has elastic properties after setting and is intended for short-term use. 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.

FDA Product Code

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a759c5ed-c0a4-41d6-a871-be5921f40ff0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 30, 2016