Essix A+ 10060
GUDID D746100601
Essix A+ Plastic .060 x 4.92" Square 50 PK
RAINTREE ESSIX INC.
Dental implant template, radiographic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic| Primary Device ID | D746100601 |
| NIH Device Record Key | 517848da-bf91-423c-ac70-690614b8c1f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Essix A+ |
| Version Model Number | 10060 |
| Catalog Number | 10060 |
| Company DUNS | 801157132 |
| Company Name | RAINTREE ESSIX INC. |
| Device Count | 50 |
| 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 | D746100600 [Unit of Use] |
| HIBCC | D746100601 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062828
FDA Product Code
| MQC | Mouthguard, prescription |
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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