| Primary Device ID | D746826041 |
| NIH Device Record Key | 8d55a1c6-b0d9-4968-81ed-4f1e3b2866af |
| Commercial Distribution Discontinuation | 2021-02-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Bonding Buttons |
| Version Model Number | 82604 |
| Catalog Number | 82604 |
| Company DUNS | 801157132 |
| Company Name | RAINTREE ESSIX INC. |
| Device Count | 10 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746826040 [Unit of Use] |
| HIBCC | D746826041 [Primary] |
| NXC | Aligner, sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-09-23 |
| Device Publish Date | 2016-09-24 |
| D74627310701 - VISTADENT® OC | 2021-12-17 VISTADENT® OC CONSULTANT |
| D7462731070U1 - VISTADENT® OC | 2021-12-17 VISTADENT® OC CONSULTANT UPDATE |
| D74627310991 - VISTADENT® OC | 2021-12-17 VISTADENT® OC COMPLETE |
| D7462731099U1 - VISTADENT® OC | 2021-12-17 VISTADENT® OC COMPLETE UPDATE |
| D7462731170L1 - VISTADENT® OC | 2021-12-17 VISTADENT® OC CONSULTANT (LATIN AM) |
| D7462731199L1 - VISTADENT® OC | 2021-12-17 VISTADENT® OC COMPLETE LATIN AMERICA |
| D74627313991 - VISTADENT® OC | 2021-12-17 VISTADENT® OC SUBSCRIPTION EAST |
| D74627314991 - VISTADENT® OC | 2021-12-17 VISTADENT® OC SUBSCRIPTION LAT AMERICA |