Clenchy 55-0160-0505
GUDID D78855016005050
Aligner Removers Ortho Clenchy 10Pt/2pks
Gc Orthodontics America Inc.
Orthodontic positioner seater| Primary Device ID | D78855016005050 |
| NIH Device Record Key | 2f8b19a3-4c8d-44cb-bce2-2fcb0deff54b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clenchy |
| Version Model Number | 55-0160-0505 |
| Catalog Number | 55-0160-0505 |
| Company DUNS | 063167128 |
| Company Name | Gc Orthodontics America Inc. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D78855016005050 [Unit of Use] |
| HIBCC | D78855016005051 [Primary] |
FDA Product Code
| ECS | PUSHER, BAND, ORTHODONTIC |
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 | 2023-03-22 |
| Device Publish Date | 2023-03-14 |
Devices Manufactured by Gc Orthodontics America Inc.
| D78811201CC511201 - EXPERIENCE | 2023-04-07 EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345 |
| D78811202AA597521 - EXPERIENCE | 2023-04-07 EXPC CCO U5-5 EXPM MBT L5-5 022 hks345 |
| D78812202AA519151 - EXPERIENCE | 2023-04-07 EXCM U5-5 EXPM L5-5 MBT 022 HK345 |
| D788122C0500101 - EXPERIENCE | 2023-04-07 EXMC ROTH 022 U5-5 HK 345 |
| D788151CC5S0101 - CHIC | 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5 |
| D788152CC5S0101 - CHIC | 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5 |
| D788312BB5GP201 - LEGEND | 2023-04-07 LMI GOLD MBT 022 U/L 6-6 HK 345 |
| D788312CC542191 - LEGEND | 2023-04-07 LMI ROTH U 2-2 MBT 345 HK 345 |
Trademark Results [Clenchy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLENCHY 88527855 not registered Live/Pending |
IDM Tooling LLC 2019-07-22 |
 CLENCHY 88147974 not registered Live/Pending |
IDM TOOLING LLC 2018-10-09 |
CLENCHY 88147974 not registered Live/Pending |
Freitas, Michael Woodford 2018-10-09 |
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