GC CROWNTEK™
- Primary DI
- D6584120631
- Brand
- GC CROWNTEK™
- Company
- Gc America Inc.
- Model
- 412063
- Catalog number
- 412063
- Device description
- GC CROWNTEK™ Starter Package, 5 crowns each of 35 sizes, Upper Right Central Incisors: 1+.3, 1+.4, 1 +.5, 1+.6, 1+.7, Upper Right Cuspids 3+.5, 3+.6, Upper Left Central Incisors: +1.3, _1.4, +1.5, +1.6, +1.7, Upper Left Cuspids: +3.5, +3.6, Upper Right Laterals: 2+.2, 2+.3, 2+.4, 2+.5, Lower Right Cuspids: 3-.3, 3-.4, Upper Left Laterals: +2.2, +2.3, +2.4, +2.5, Lower Left Cuspids: -3.3, -3.4, Lower Centrals & Laterals: -1-2-.6, -1-2-.7, Bicuspids: 2, 3, 4, 5, 6, 7. 8
- Published
- 2017-02-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| ELZ | CROWN, PREFORMED |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELZ | Crown, Preformed | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D6584120631 | Primary | HIBCC | 0 | |
| D6584120630 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Preformed dental crown, temporary | A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Room temperature |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(708)597-0900 | customerservice@gcamerica.com |
Regulatory Flags
- DUNS number
- 005473608
- Device count
- 175
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 14550565002269 | Cytrans Granules | 10041295 | 10041295 | 2026-03-03 |
| 14550565002276 | Cytrans Granules | 10041296 | 10041296 | 2026-03-03 |
| D047014615 | Cytrans Granules | 10041295 | 10041295 | 2026-03-03 |
| D047014616 | Cytrans Granules | 10041296 | 10041296 | 2026-03-03 |
| D6581200012 | COE ALGINATE™ | 120001 | 120001 | 2016-08-01 |
| D6581200051 | COE ALGINATE™ | 120005 | 120005 | 2016-08-01 |
| D6581200251 | COE ALGINATE™ | 120025 | 120025 | 2016-08-01 |
| D6581201012 | COE ALGINATE™ | 120101 | 120101 | 2016-08-01 |
| D6581210012 | COE ALGINATE™ | 121001 | 121001 | 2016-08-01 |
| D6581211012 | COE ALGINATE™ | 121101 | 121101 | 2016-08-01 |
| D6581240012 | COE HYDROPHILIC GEL™ | 124001 | 124001 | 2016-08-01 |
| D6581241012 | COE HYDROPHILIC GEL™ | 124101 | 124101 | 2016-08-01 |
| D6581241251 | COE HYDROPHILIC GEL™ | 124125 | 124125 | 2016-08-01 |
| D6581310022 | COE-FLEX® | 131002 | 131002 | 2016-08-01 |
| D6581310032 | COE-FLEX® | 131003 | 131003 | 2016-08-01 |
| D6581310042 | COE-FLEX® | 131004 | 131004 | 2016-08-01 |
| D6581310052 | COE-FLEX® | 131005 | 131005 | 2016-08-01 |
| D6581311022 | COE-FLEX® | 131102 | 131102 | 2016-08-01 |
| D6581311032 | COE-FLEX® | 131103 | 131103 | 2016-08-01 |
| D6581311042 | COE-FLEX® | 131104 | 131104 | 2016-08-01 |
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| 00810118107085 | NuSmile ReVIVE Crowns | NUSMILE, LTD. | ELZ | 2025-11-26 |
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