Essix ACE 1A347-50
GUDID D7461A347501
Essix ACE .030 x 125mm Square 50pk
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| Primary Device ID | D7461A347501 |
| NIH Device Record Key | cbfd1f3e-8694-4a21-aa01-980c146b6f91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Essix ACE |
| Version Model Number | 1A347-50 |
| Catalog Number | 1A347-50 |
| 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(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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7461A347500 [Unit of Use] |
| HIBCC | D7461A347501 [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 ACE]
| D74625325301 | ESSIX ACE (BX/100) RM008 (SAME AS RAINTREE PART 1A420) |
| D7461A4781 | Essix ACE 040 x 4.875" PCTG Vacuum Square 100pk |
| D7461A450SH1 | Essix ACE 040 x 5" PCTG Vacuum Square 20PK |
| D7461A450501 | Essix ACE .040 x 5" PCTG Square 50pk |
| D7461A4501 | Essix ACE 040 x 5" x 5" PCTG Vacuum Square 100pk |
| D7461A425SH1 | Essix ACE 040 x 125mm PCTG Vacuum Circle 20pk |
| D7461A425501 | Essix ACE .040 x 125mm PCTG Circle 50pk |
| D7461A4251 | Essix ACE 040 x 125mm PCTG Vacuum Circle 100pk |
| D7461A420501 | Essix ACE .040 x 120mm PCTG Circle 50pk |
| D7461A4201 | Essix ACE 040 x 120mm PCTG Vacuum Circle 100pk |
| D7461A350SH1 | Essix ACE 030 x 5" PCTG Vacuum Square 20PK |
| D7461A350501 | Essix ACE .030 x 5" PCTG Square 50pk |
| D7461A3501 | Essix ACE 030 x 5" PCTG Vacuum Square 100pk |
| D7461A347501 | Essix ACE .030 x 125mm Square 50pk |
| D7461A3471 | Essix ACE 030 x 125mm Square 100/PK |
| D7461A325SH1 | Essix ACE 030 x 125mm PCTG Vacuum Circle 20PK |
| D7461A325501 | Essix ACE .030 x 125mm PCTG Circle 50pk |
| D7461A3251 | Essix ACE 030 x 125mm PCTG Vacuum Circle 100pk |
| D7461A320501 | Essix ACE .030 x 120mm PCTG Circle 50pk |
| D7461A3201 | Essix ACE 030 x 120mm PCTG Vacuum Circle 100pk |
Trademark Results [Essix ACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESSIX ACE 78353800 3093929 Live/Registered |
DENTSPLY SIRONA ORTHODONTICS INC. 2004-01-19 |
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