GC Reline ™ 001859
GUDID D0470018591
GC Reline ™ 56 g (48 mL) cartridge (Ultra Soft)
Gc America Inc.
Denture reliner, elastic, short-term| Primary Device ID | D0470018591 |
| NIH Device Record Key | 8b8f4cea-6e60-4d3f-9631-affa57d0b8fa |
| Commercial Distribution Discontinuation | 2017-11-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GC Reline ™ |
| Version Model Number | 001859 |
| Catalog Number | 001859 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Device Dimensions
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
| Weight | 56 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0470018591 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990736
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-02-03 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [GC Reline ™]
| 10386040007085 | GC Reline ™ Bonding Agent, 12g |
| 10386040007078 | GC Reline ™ Intro Package, Standard Package Powder/ Liquid (1 x 80g powder, 1 x 50mL liquid, 1 |
| 10386040003766 | GC Reline ™ 80g powder |
| 10386040000871 | GC Reline ™ 50mL liquid |
| D0470018591 | GC Reline ™ 56 g (48 mL) cartridge (Ultra Soft) |
| D0470006032 | GC Reline ™ Modifier, 1-1 Pack, A&B 10 g (9 mL) each, mixing pad & sponge |
| D0470006022 | GC Reline ™ Primer R, 12 g (13 mL) liquid |
| D0470006012 | GC Reline ™ Extra soft 56 g (48 mL) cartridge |
| D0470006002 | GC Reline ™ Extra Soft Intro Package 1 (48mL) cartridge of extra soft, 6 type 2L mixing tips, |
| D0470005992 | GC Reline ™ Soft 62 g (48 mL) cartridge |
| D0470005982 | GC Reline ™ Soft Intro Package 1 (48mL) cartridge, 6 type 2L mixing tips, 13mL bottle of Prime |
| D6583461911 | GC Reline ™ 50mL liquid |
| D6583460941 | GC Reline ™ Bonding Agent, 12g |
| D6583460021 | GC Reline ™ 80g powder |
| D6583460011 | GC Reline ™ Intro Package, Standard Package Powder/ Liquid (1 x 80g powder, 1 x 50mL liquid, 1 |
Trademark Results [GC Reline]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC RELINE 75854069 2479267 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 1999-11-19 |
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