EXA Advanced 138116
GUDID 00386040013454
EXA Advanced Heavy Normal Value Pack
Gc America Inc.
Silicone dental impression material| Primary Device ID | 00386040013454 |
| NIH Device Record Key | c670fe3b-2021-4f44-bdbf-de54e2bf8d43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXA Advanced |
| Version Model Number | 138116 |
| Catalog Number | 138116 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 8 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386040013454 [Unit of Use] |
| GS1 | 10386040013451 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K955932
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 | 2022-08-22 |
| Device Publish Date | 2022-08-12 |
On-Brand Devices [EXA Advanced]
| 00386040013485 | EXA Advanced Injection Normal Value Pack |
| 00386040013478 | EXA Advanced Mono Normal Value Pack |
| 00386040013461 | EXA Advanced Regular Normal Value Pack |
| 00386040013454 | EXA Advanced Heavy Normal Value Pack |
| 00386040013447 | EXA Advanced Injection Fast Value Pack |
| 00386040013430 | EXA Advanced Mono Fast Set Value Pack |
| 00386040013423 | EXA Advanced Regular Fast Set Value Pack |
| 00386040013416 | EXA Advanced Heavy Fast Set Value Pack |
| 00386040013348 | EXA Advanced Inject 2 Pak w/Mixing Tips |
| 00386040013331 | EXA Advanced Mono 2 Pak w/Mixing Tips |
| 00386040013324 | EXA Advanced Regular 2 Pak w/Mixing Tips |
| 00386040013317 | EXA Advanced Heavy 2 Pak w/Mixing Tips |
| 00386040013294 | EXA Advanced Mono Fast 2 Pak w/Tips |
| 00386040013287 | EXA Advanced Reg Fast 2 Pak w/Tips |
| 00386040013270 | EXA Advanced Heavy Fast 2 Pak w/Tips |
Trademark Results [EXA Advanced]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXA ADVANCED 79308167 not registered Live/Pending |
GC Corporation 2021-02-15 |
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