ProTech Soft Reline

Basic Information

• Brand Name: ProTech Soft Reline
• Primary DI: D814SRC12C1
• Version / Model: SRC12C
• Catalog Number: SRC12C
• Company Name: PROTECH PROFESSIONAL PRODUCTS INC
• Labeler DUNS: 117374900
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 5
• Public Version Date: 2019-05-20
• Public Version Status: Update
• Public Device Record Key: 0eca96f9-b025-4c66-9b8e-472e9eebfae5
• Distribution End Date: 2017-04-05

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34769	Denture reliner, elastic, short-term	A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D814SRC12C1	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K151646	000