EXACLEAR 008482
GUDID 14548161333740
EXACLEAR Translucent 2 VPS Cartridges (with 6 VPS Mixing Tips; size L; 48 mL).
Gc America Inc.
Polyether dental impression material| Primary Device ID | 14548161333740 |
| NIH Device Record Key | a6ae65d0-0c77-4719-a6ec-fd46864a15fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACLEAR |
| Version Model Number | 008482 |
| Catalog Number | 008482 |
| 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 |
Device Dimensions
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161333740 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K933206
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
Devices Manufactured by Gc America Inc.
| D0470001812 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® Core 1-2 Package (1 x 35 g powder, 2 x 5 mL liquid, 1 x scoop, 1 x mixing pad) |
| D0470001822 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® Core 35 g powder btl. |
| D0470001832 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® Core (5.1mL) liquid btl |
| D0470001842 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® A1, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories) |
| D0470001852 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® A2, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories) |
| D0470001862 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® A3, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories) |
| D0470001871 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® A3.5, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories) |
| D0470001881 - GC Fuji II LC® | 2025-02-03 GC Fuji II LC® A4, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories) |
Trademark Results [EXACLEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXACLEAR 79246430 not registered Live/Pending |
GC Corporation 2018-09-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.