FDA Registration
Active
🇺🇸 United States
anax USA
Reg #: 3009432160
·
FEI: 3009432160
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- anax USA
- Registration Number
- 3009432160
- FEI Number
- 3009432160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 406 I ST NW ARDMORE
- City
- Ardmore
- State
- OK
- ZIP
- 73401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123638
Owner / Operator
- Firm Name
- anaxdent North America
- Operator Number
- 10039879
- Address
- 406 I ST NW
- City
- Ardmore
- State
- OK
- Postal Code
- 73401
- Country
- US
- Correspondent
- Tay Harvey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2015-12-31 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-03-07 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2021-05-13 |
| Material, Impression | ELW | Class 2 | Dental | No | 2015-12-31 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2023-01-04 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-02-16 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2013-04-04 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2020-09-09 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2025-09-08 |
Proprietary Names
Pekkton Ivory
anaxdent
New Outline
CM Connect
Soprano
Soprano Surface
Celara Extended-Pour Alginate
anaxcam The Show
anaxPINK
anaxGUM
anaxBLEND
Mock-up Direct
ACRYLINE
3Delta UNlimited
Establishment Types
Complaint File Establishment per 21 CFR 820.198