GC RELINE™ II 010267

GUDID 14548161321396

GC RELINE™ II Cartridge ExtraSoft: 1 x57g (48mL)

Gc America Inc.

Denture reliner, soft, professional
Primary Device ID14548161321396
NIH Device Record Keyc431dddd-c024-416a-a0f8-38241610f7d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC RELINE™ II
Version Model Number010267
Catalog Number010267
Company DUNS005473608
Company NameGc America Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS114548161321396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-15
Device Publish Date2022-08-05

On-Brand Devices [GC RELINE™ II]

14548161321457GC RELINE™ II Disposable Brush (6)
14548161321440GC RELINE™ II Wheel for Finishing (12)
14548161321433GC RELINE ™ II Point for Trimming (3)
14548161321426GC RELINE™ II Remover (for Resin): 1 x 5g (5.5mL)
14548161321419GC RELINE™ II Primer for Resin: 1 x 8g (10mL)
14548161321402GC RELINE™ II Finishing Material: 1 each A & B 10g(9mL)
14548161321396GC RELINE™ II Cartridge ExtraSoft: 1 x57g (48mL)
14548161321389GC RELINE™ II Cartridge Soft: 1 x 61g (48mL)
14548161321372GC RELINE™ II Intro Kit ExtraSoft contains: 1 GC RELINE II Cartridge ExtraSoft 57g (48mL), 1
14548161321365GC RELINE™ II Intro Kit Soft contains: 1 GC RELINE II Cartridge Soft 61g(48mL), 1 GC RELINE II
14548161321358GC RELINE™ II Cartridge ExtraExtraSoft: 1 x 55g(48mL)
14548161321341GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g

Trademark Results [GC RELINE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GC RELINE
GC RELINE
75854069 2479267 Live/Registered
TRADEMARK HOLDINGS OF ILLINOIS LLC
1999-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.