Essix A+ 11031
GUDID D746110311
Essix A+ Plastic .030 x 120mm PETG Vacuum Circles 100PK
RAINTREE ESSIX INC.
Dental implant template, radiographic| Primary Device ID | D746110311 |
| NIH Device Record Key | 832fa53b-a351-4098-a5c0-03de0d88f8f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Essix A+ |
| Version Model Number | 11031 |
| Catalog Number | 11031 |
| Company DUNS | 801157132 |
| Company Name | RAINTREE ESSIX INC. |
| Device Count | 100 |
| 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 | true |
| 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
| 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 | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746110310 [Unit of Use] |
| HIBCC | D746110311 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062828
FDA Product Code
| NXC | Aligner, sequential |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Essix A+]
| D746135001 | Essix A+ plastic .120mm x 5" Square 25/PK |
| D746115451 | Essix A+ Plastic- .040in 135mm CIR |
| D746110811 | Essix A+ .080 x 120mm Circle 50/PK |
| D74611080251 | Essix A+ Plastic .080 x 125mm Cir For Sale 25Pk |
| D746110801 | Essix A+ Plastic .080 x 125mm PETG Vacuum Circles 50PK |
| D746110611 | Essix A+ Plastic .060 x 120mm Circles 50PK |
| D746110601 | Essix A+ Plastic .060 x 125mm PETG Vacuum Circles 50PK |
| D746110411 | Essix A+ Plastic .040 x 120mm Circle 100PK |
| D74611040SH1 | Essix A+ .040 x 125mm Circle 20PK |
| D746110401 | Essix A+ .040 x 125mm Circle (100PK) |
| D746110311 | Essix A+ Plastic .030 x 120mm PETG Vacuum Circles 100PK |
| D74611030SH1 | Essix A+ Plastic .030 x 125mm Circle 20PK |
| D746110301 | Essix A+ Plastic .030 x 125mm Circle 100PK |
| D746110211 | Essix A+ plastic .020 x 120mm circle 100PK |
| D74611020SH1 | Essix A+ Plastic .020 x 125mm circle 20PK |
| D746110201 | Essix A+ Plastic .020 x 125mm circle 100PK |
| D746100851 | Essix A+ Plastic .080 x 5" Square 50PK |
| D746100801 | Essix A+ Plastic .080 x 125 For Sale 50Pk |
| D74610065SH1 | Essix A+ Plastic .060 x 5" Square 20PK |
| D74610065251 | Essix A+ Plastic .060 x 5" Square 25 PK |
| D746100651 | Essix A+ Plastic .060 x 5" Square 50PK |
| D746100601 | Essix A+ Plastic .060 x 4.92" Square 50 PK |
| D74610045SH1 | Essix A+ Plastic .040 x 5" PETG Vacuum Square 20PK |
| D74610045501 | Essix A+ Plastic .040 x 5" PETG Vacuum Square 50Pk |
| D746100451 | Essix A+ Plastic .040 x 5" PETG Vacuum Square 100PK |
| D746100401 | Essix A+ plastic .040 x 4.92" square 100PK |
| D74610035SH1 | Essix A+ Plastic .030 x 5" PETG Vacuum Square 20PK |
| D74610035501 | Essix A+ Plastic .030 x 5" PETG Vacuum Square 50PK |
| D746100351 | Essix A+ Plastic .030 x 5" PETG Vacuum Square 100PK |
| D746100301 | Essix A+ Plastic .030 x 4.92" Square 100/PK |
| D74610025SH1 | Essix A+ .020 x 5" square 20PK |
| D74610025501 | Essix A+ .020 x 5" square 50PK |
| D746100251 | Essix A+ .020 x 5" square 100PK |
| D746100201 | Essix A+ Plastic .020 x 4.92"' Square 100PK |
Trademark Results [Essix A+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESSIX A+ 76016434 2681615 Dead/Cancelled |
RAINTREE ESSIX INC. 2000-04-03 |
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