CERASMART™ 012507
GUDID 04548161320910
CERASMART™ 270 14L Universal A3.5 HT 5p Block
Gc America Inc.
Dental implant suprastructure, permanent, preformed| Primary Device ID | 04548161320910 |
| NIH Device Record Key | 7c707ac6-5dfa-400a-b9fc-424939dc8a81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERASMART™ |
| Version Model Number | 012507 |
| Catalog Number | 012507 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 5 |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548161320910 [Unit of Use] |
| GS1 | 14548161320917 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133824
FDA Product Code
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
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 |
On-Brand Devices [CERASMART™]
| 04548161320965 | CERASMART™ 270 14L Universal A3.5 LT 5p Block |
| 04548161320958 | CERASMART™ 270 14L Universal A3 LT 5p Block |
| 04548161320941 | CERASMART™ 270 14L Universal A2 LT 5p Block |
| 04548161320927 | CERASMART™ 270 14L Universal B1 HT 5p Block |
| 04548161320910 | CERASMART™ 270 14L Universal A3.5 HT 5p Block |
| 04548161320859 | CERASMART™ 270 14L Universal A3 HT 5p Block |
| 04548161320743 | CERASMART™ 270 14L Universal A2 HT 5p Block |
| 04548161320651 | CERASMART™ 270 14L Universal BL 5p Block |
| 04548161320644 | CERASMART™ 270 14L Universal B1 LT 5p Block |
| 04548161320637 | CERASMART™ 270 14L Universal A1 HT 5p Block |
| 04548161320620 | CERASMART™ 270 14L Cerec BL 5p Block |
| 04548161320613 | CERASMART™ 270 14L Cerec B1 LT 5p Block |
| 04548161320606 | CERASMART™ 270 14L Cerec A3.5 LT 5p Block |
| 04548161320590 | CERASMART™ 270 14L Cerec A3 LT 5p Block |
| 04548161320583 | CERASMART™ 270 14L Cerec A2 LT 5p Block |
| 04548161320576 | CERASMART™ 270 14L Cerec A1 LT 5p Block |
| 04548161320569 | CERASMART™ 270 14L Cerec B1 HT 5p Block |
| 04548161320552 | CERASMART™ 270 14L Cerec A3.5 HT 5p Block |
| 04548161320545 | CERASMART™ 270 14L Cerec A3 HT 5p Block |
| 04548161320538 | CERASMART™ 270 14L Cerec A2 HT 5p Block |
| 04548161320514 | CERASMART™ 270 14L Cerec A1 HT 5p Block |
| 04548161320507 | CERASMART™ 270 14 Universal BL 5p Block |
| 04548161320491 | CERASMART™ 270 14 Universal B1 LT 5p Block |
| 04548161320484 | CERASMART™ 270 14 Universal A3.5 LT 5p Block |
| 04548161320477 | CERASMART™ 270 14 Universal A3 LT 5p Block |
| 04548161320460 | CERASMART™ 270 14 Universal A2 LT 5p Block |
| 04548161320453 | CERASMART™ 270 14 Universal A1 LT 5p Block |
| 04548161320446 | CERASMART™ 270 14 Universal B1 HT 5p Block |
| 04548161320439 | CERASMART™ 270 14 Universal A3.5HT 5p Block |
| 04548161320422 | CERASMART™ 270 14 Universal A3 HT 5p Block |
| 04548161320408 | CERASMART™ 270 14 Universal A2 HT 5p Block |
| 04548161320392 | CERASMART™ 270 14 Universal A1 HT 5p Block |
| 04548161320385 | CERASMART™ 270 14 Cerec BL 5p Block |
| 04548161320378 | CERASMART™ 270 14 Cerec B1 LT 5p Block |
| 04548161320361 | CERASMART™ 270 14 Cerec A3.5 LT 5p Block |
| 04548161320354 | CERASMART™ 270 14 Cerec A3 LT 5p Block |
| 04548161320347 | CERASMART™ 270 14 Cerec A2 LT 5p Block |
| 04548161320330 | CERASMART™ 270 14 Cerec A1 LT 5p Block |
| 04548161320323 | CERASMART™ 270 14 Cerec B1 HT 5p Block |
| 04548161320316 | CERASMART™ 270 14 Cerec A3.5 HT 5p Block |
| 04548161320293 | CERASMART™ 270 14 Cerec A3 Ht 5p Block |
| 04548161320286 | CERASMART™ 270 14 Cerec A2 HT 5p Block |
| 04548161320279 | CERASMART™ 270 14 Cerec A1 HT 5p Block |
| 04548161320262 | CERASMART™ 270 12 Universal BL 5p Block |
| 04548161320255 | CERASMART™ 270 12 Universal B1 LT 5p Block |
| 04548161320248 | CERASMART™ 270 12 Universal A3.5 LT 5p Block |
| 04548161320231 | CERASMART™ 270 12 Universal A3 LT 5p Block |
| 04548161320224 | CERASMART™ 270 12 Universal A2 LT 5p Block |
| 04548161320217 | CERASMART™ 270 12 Universal A1 LT 5p Block |
| 04548161320200 | CERASMART™ 270 12 Universal B1 HT 5p Block |
Trademark Results [CERASMART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERASMART 86333135 4783289 Live/Registered |
GC CORPORATION 2014-07-10 |
 CERASMART 86141651 4704933 Live/Registered |
GC CORPORATION 2013-12-12 |
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