Primary Device ID | D80782431001 |
NIH Device Record Key | 306d7ca6-017e-40f1-815e-123e10c03efb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ovation® |
Version Model Number | 82-431-00 |
Catalog Number | 82-431-00 |
Company DUNS | 116903307 |
Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
Device Count | 10 |
DM Exempt | true |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D80782431000 [Unit of Use] |
HIBCC | D80782431001 [Primary] |
EJF | BRACKET, METAL, ORTHODONTIC |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-10 |
Device Publish Date | 2019-09-30 |
D807K82055261 | OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK |
D807K82055241 | OVATION® Base Rx 022 UL/5-5 CS-BC MHK |
D807K82055221 | OVATION® Base Rx 022 UL/5-5 CS-BC DHK |
D80783452101 | OVATION® Base Rx 022/LL5 -22T-1A 4DHK |
D80783452001 | OVATION® Base Rx 022/LL5 -22T-1A 4D |
D80783442101 | OVATION® Base Rx 022/LL4 -17T-1A 4DHK |
D80783442001 | OVATION® Base Rx 022/LL4 -17T-1A 4D |
D80783352101 | OVATION® Base Rx 022/LR5 -22T-1A 4DHK |
D80783352001 | OVATION® Base Rx 022/LR5 -22T-1A 4D |
D80783342101 | OVATION® Base Rx 022/LR4 -17T-1A 4DHK |
D80783342001 | OVATION® Base Rx 022/LR4 -17T-1A 4D |
D80783242901 | OVATION® Base Rx 022/UL4 -7T 0A 2D MSHK |
D80783242101 | OVATION® Base Rx 022/UL4 -7T 2D HK |
D80783242001 | OVATION® Base Rx 022/UL4&5 -7T 0A 2D |
D80783241101 | OVATION® Base Rx 018/UL4 -7T 2D HK |
D80783142901 | OVATION® Base Rx 022/UR4 -7T 0A 2D MSHK |
D80783142101 | OVATION® Base Rx 022/UR4 -7T 2D HK |
D80783142001 | OVATION® Base Rx 022/UR4&5 -7T 0A 2D |
D80783141901 | OVATION® Base Rx 018/UR4 -7T 0A 2D MSHK |
D80783141101 | OVATION® Base Rx 018/UR4 -7T 2D HK |
D80783141001 | OVATION® Base Rx 018/UR4&5 -7T 0A 2D |
D80782452101 | Ovation® Base Rx022/LL5 -22T-1A4D HK |
D80782452001 | Ovation® Base Rx022/LL5 -22T-1A4D |
D80782451121 | Ovation® Base Rx018/LL5 -22T-1A4D XOB HK |
D80782451101 | Ovation® Base Rx018/LL5 -22T-1A4D HK |
D80782451001 | Ovation® Base Rx018/LL5 -22T-1A4D |
D80782442101 | Ovation® Base Rx022/LL4 -17T-1A4D HK |
D80782442001 | Ovation® Base Rx022/LL4 -17T-1A4D |
D80782441121 | Ovation® Base Rx018/LL4 -17T-1A4D XOB HK |
D80782441101 | Ovation® Base Rx018/LL4 -17T-1A4D HK |
D80782441001 | Ovation® Base Rx018/LL4 -17T-1A4D |
D80782432111 | Ovation® Base Rx XT022/LL3 0T 5A PST |
D80782432101 | Ovation® Base Rx022/LL3 -11T7A2MHK |
D80782432001 | Ovation® Base Rx022/LL3 -11T7A 2M |
D80782431111 | Ovation® Base Rx XT018/LL3 0T 5A PST |
D80782431101 | Ovation® Base Rx018/LL3 -11T7A2MHK |
D80782431001 | Ovation® Base Rx018/LL3 -11T7A 2M |
D80782412001 | Ovation® Base Rx022/LL1-2 -1T 2A |
D80782411001 | Ovation® Base Rx018/LL1-2 -1T 2A |
D80782352101 | Ovation® Base Rx022/LR5 -22T-1A4D HK |
D80782352001 | Ovation® Base Rx022/LR5 -22T-1A4D |
D80782351121 | Ovation® Base Rx018/LR5 -22T-1A4D XOB HK |
D80782351101 | Ovation® Base Rx018/LR5 -22T-1A4D HK |
D80782351001 | Ovation® Base Rx018/LR5 -22T-1A4D |
D80782342101 | Ovation® Base Rx022/LR4 -17T-1A4D HK |
D80782342001 | Ovation® Base Rx022/LR4 -17T-1A4D |
D80782341121 | Ovation® Base Rx018/LR4 -17T-1A4D XOB HK |
D80782341101 | Ovation® Base Rx018/LR4 -17T-1A4D HK |
D80782341001 | Ovation® Base Rx018/LR4 -17T-1A4D |
D80782332101 | Ovation® Base Rx022/LR3 -11T7A2MHK |