FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Essix Embrace®
DI: D7461E3471
·
Model: 1E347
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Essix Embrace®
- Primary DI
- D7461E3471
- Version / Model
- 1E347
- Catalog Number
- 1E347
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2022-12-19
- Public Version Status
- Update
- Public Device Record Key
- ddab92e1-f668-4325-84f5-fcb77e052b69
- Distribution End Date
- 2021-01-20
Device Description
Essix Embrace® Plastic - .030in 125mm Sq
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMY | POSITIONER, TOOTH, PREFORMED | Dental | 872.5525 | 1 |
| MQC | Mouthguard, prescription | Unknown | U | |
| NXC | Aligner, sequential | Dental | 872.5470 | 2 |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7461E3471 | HIBCC | ||||
| Unit of Use | D7461E3470 | HIBCC |
Customer Contacts
- Phone
- +1(800)883-8733
- [email protected]