Ovation® C K310-532-11
GUDID D807K310532111
OVATION® C RT RX 022 U5-5/L3-3 CS BC HK
GAC
Orthodontic bracket, ceramic| Primary Device ID | D807K310532111 |
| NIH Device Record Key | 1004121a-07ed-4544-84a0-18251b7e6d98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ovation® C |
| Version Model Number | K310-532-11 |
| Catalog Number | K310-532-11 |
| Company DUNS | 053475903 |
| Company Name | GAC |
| Device Count | 16 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D807K310532110 [Unit of Use] |
| HIBCC | D807K310532111 [Primary] |
FDA Product Code
| NJM | Bracket, ceramic, orthodontic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2017-06-26 |
On-Brand Devices [Ovation® C ]
| D807K310532111 | OVATION® C RT RX 022 U5-5/L3-3 CS BC HK |
| D807K310531111 | OVATION® C RT RX 018 U5-5/L3-3 CS BC HK |
| D807K310152111 | OVATION® C RT RX 022 U5-5 CS BC HK |
| D807310611001 | Ovation® C Base Rx 018/L1&2 0T 0A |
| D807310542101 | Ovation® C RT RX 022/U4&5 -7T 0A HK |
| D807310542001 | Ovation® C RT RX 022/U4&5 -7T 0A |
| D807310431101 | Ovation® C RT RX 018/LL3 -11T 7A 2M HK |
| D807310332101 | Ovation® C RT RX 022/LR3 -11T 7A 2M HK |
| D807310331001 | Ovation® C RT RX 018/LR3 -11T 7A 2M |
| D807310231161 | Ovation® C RT RX SP 018/UL3-2T 9A 4M HK |
| D807310231101 | Ovation® C RT RX 018/UL3 -2T 13A 4M HK |
| D807310231001 | Ovation® C RT RX 018/UL3 -2T 13A 4M |
| D807310221001 | Ovation® C RT RX 018/UL2 8T 9A |
| D807310132101 | Ovation® C RT RX 022/UR3 -2T 13A 4M HK |
| D807310132001 | Ovation® C RT RX 022/UR3 -2T 13A 4M |
| D807310131161 | Ovation® C RT RX SP 018/UR3 -2T 9A 4M HK |
| D807310131101 | Ovation® C RT RX 018/UR3-2T 13A 4M HK |
| D807310131001 | Ovation® C RT RX 018/UR3 -2T 13A 4M |
| D807310122001 | Ovation® C RT RX 022/UR2 8T 9A |
| D807310121001 | Ovation® C RT RX 018/UR2 8T 9A |
| D807310112001 | Ovation® C RT RX 022/UR1 12T 5A |
| D807310111001 | Ovation® C RT RX 018/UR1 12T 5A |
Trademark Results [Ovation]
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