FDA Registration
Active
🇺🇸 United States
Damon Retention Splint
Reg #: 2184045
·
FEI: 1000128562
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Allesee Orthodontic Appliances, Inc.
- Registration Number
- 2184045
- FEI Number
- 1000128562
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13931 Spring St
- City
- Sturtevant
- State
- WI
- ZIP
- 53177
- Country
- US
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1717 W. Collins Ave. Ca. 92867 USA, --
- City
- Orange
- State
- CA
- Postal Code
- 92867
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2004-11-04 |
Proprietary Names
Damon Retention Splint
Flat Plane Splint
Bleaching Trays
Mora/Gelb Splint
AOB Splint
Silicone Positioner (Pro-Flex)
Repositioning Splint
Starnes Orthotic Appliance
Bruxism Splint
Herbst Appliance Acrylic Splint
Intrusion Splint
Flexiclear
Elast-Acryl
Impak Positioner
Pro-Flex
Impak
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device