CERASMART® 011959
GUDID D0470119591
CERASMART® Glidewell 14 B1 LT 5p Block
Gc America Inc.
Dental implant suprastructure, permanent, preformed| Primary Device ID | D0470119591 |
| NIH Device Record Key | c57e5a0c-b4fa-46be-be94-82ce71d6940f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERASMART® |
| Version Model Number | 011959 |
| Catalog Number | 011959 |
| 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
Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
|---|---|
| HIBCC | D0470119590 [Unit of Use] |
| HIBCC | D0470119591 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-10-16 |
On-Brand Devices [CERASMART®]
| D0470119601 | CERASMART® Glidewell 14 Bleach 5p Block |
| D0470119591 | CERASMART® Glidewell 14 B1 LT 5p Block |
| D0470119581 | CERASMART® Glidewell 14 A3.5 LT 5p Block |
| D0470119571 | CERASMART® Glidewell 14 A3 LT 5p Block |
| D0470119561 | CERASMART® Glidewell 14 A2 LT 5p Block |
| D0470119551 | CERASMART® Glidewell 14 A1 LT 5p Block |
| D0470119541 | CERASMART® Glidewell 14 B1 HT 5p Block |
| D0470119531 | CERASMART® Glidewell 14 A3.5 HT 5p Block |
| D0470119521 | CERASMART® Glidewell 14 A3 HT 5p Block |
| D0470119511 | CERASMART® Glidewell 14 A2 HT 5p Block |
| D0470119501 | CERASMART® Glidewell 14 A1 HT 5p Block |
| D0470086852 | CERASMART® Universal (Size 14L), Shade Bleach, 5 pieces |
| D0470086842 | CERASMART® Universal (Size 14L), B1 Low Translucency, 5 pieces |
| D0470086832 | CERASMART® Universal (Size 14L), A3.5 LowTranslucency, 5 pieces |
| D0470086822 | CERASMART® Universal (Size 14L), A3 Low Translucency, 5 pieces |
| D0470086812 | CERASMART® Universal (Size 14L), A2 Low Translucency, 5 pieces |
| D0470086802 | CERASMART® Universal (Size 14L), A1 Low Translucency, 5 pieces |
| D0470086792 | CERASMART® Universal (Size 14L), B1 High Translucency, 5 pieces |
| D0470086782 | CERASMART® Universal (Size 14L), A3.5 High Translucency, 5 pieces |
| D0470086772 | CERASMART® Universal (Size 14L), A3 High Translucency, 5 pieces |
| D0470086762 | CERASMART® Universal (Size 14L), A2 HighTranslucency, 5 pieces |
| D0470086752 | CERASMART® Universal (Size 14L), A1 High Translucency, 5 pieces |
| D0470086742 | CERASMART® Universal (Size 14), BL Shade Bleach, 5 pieces |
| D0470086732 | CERASMART® Universal (Size 14), B1 Low Translucency, 5 pieces |
| D0470086722 | CERASMART® Universal (Size 14), A3.5 Low Translucency, 5 pieces |
| D0470086712 | CERASMART® Universal (Size 14), A3 Low Translucency, 5 pieces |
| D0470086702 | CERASMART® Universal (Size 14), A2 Low Translucency, 5 pieces |
| D0470086692 | CERASMART® Universal (Size 14), A1 Low Translucency, 5 pieces |
| D0470086682 | CERASMART® Universal (Size 14), B1 High Translucency, 5 pieces |
| D0470086672 | CERASMART® Universal (Size 14), A3.5 High Translucency, 5 pieces |
| D0470086662 | CERASMART® Universal (Size 14), A3 High Translucency , 5 pieces |
| D0470086652 | CERASMART® Universal (Size 14), A2 High Translucency, 5 pieces |
| D0470086642 | CERASMART® Universal (Size 14), A1 High Translucency, 5 pieces |
| D0470086632 | CERASMART® Universal (Size 12), BL Shade Bleach, 5 pieces |
| D0470086622 | CERASMART® Universal (Size 12), B1 Low Translucency, 5 pieces |
| D0470086612 | CERASMART® Universal (Size 12), A3.5 Low Translucency, 5 pieces |
| D0470086602 | CERASMART® Universal (Size 12), A3 Low Translucency, 5 pieces |
| D0470086592 | CERASMART® Universal (Size 12), A2 Low Translucency, 5 pieces |
| D0470086582 | CERASMART® Universal (Size 12), A1 Low Translucency, 5 pieces |
| D0470086572 | CERASMART® Universal (Size 12), B1 High Translucency, 5 pieces |
| D0470086562 | CERASMART® Universal (size 12), A3.5 High Translucency, 5 pieces |
| D0470086552 | CERASMART® Universal (Size 12), A3 High Translucency, 5 pieces |
| D0470086542 | CERASMART® Universal (Size 12), A2 High Translucency, 5 pieces |
| D0470086532 | CERASMART® Universal (Size 12), A1 High Translucency, 5 pieces |
| D0470084072 | CERASMART® for Planmill 14L Bleach 5 pieces |
| D0470084062 | CERASMART® for Planmill 14L B1LT 5 pieces |
| D0470084052 | CERASMART® for Planmill 14L A3.5LT 5 pieces |
| D0470084042 | CERASMART® for Planmill 14L A3 LT 5 pieces |
| D0470084032 | CERASMART® for Planmill 14L A2 LT 5 pieces |
| D0470084022 | CERASMART® for Planmill 14L A1 LT 5 pieces |
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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