Clenchy 55-0160-0505
GUDID D78855016005050
Aligner Removers Ortho Clenchy 10Pt/2pks
Gc Orthodontics America Inc.
Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic positioner seater Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use| 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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