FDA Registration
Active
🇺🇸 United States
Allesee Orthodontic Appliances, Inc.
Reg #: 2184045
·
FEI: 1000128562
·
Expires 2026
Products
6
Proprietary Names
72
Establishment Types
5
Classifications
6
Registration Details
- Registration Name
- Allesee Orthodontic Appliances, Inc.
- Registration Number
- 2184045
- FEI Number
- 1000128562
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13931 Spring St
- City
- Sturtevant
- State
- WI
- ZIP
- 53177
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040874
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1889 W Mission Blvd, --
- City
- Pomona
- State
- CA
- Postal Code
- 91766
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2023-11-17 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2002-07-02 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2005-07-29 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2006-03-29 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2002-07-02 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2004-11-04 |
Proprietary Names
Adaptor
Jackson Expander
Hex Appliance (Hilgers)
Bluegrass Tongue Trainer
Activators
Spring Loaded Space Regainer
Frankel
W Arch Expander
Distal Jet Molar Uprighter
Dischinger Lower Expansion Appliance
Lower Bi-Helix
Kiddie Partial
DeLuke Bonded Framless Expander
MAH Freedom Appliances
Orthopedic Corrector
ACCO Expander
Shamey Expander
Distal Jet
Fan Expider Expander
Goshgarian Transpalatal Arch
Nance Button
Vertical Crib
Hilgers Pendex
MCLR
Hilgers Pendulum
Transpalatal Arch
Lingual Arch
Mayes Penguin
Bionator
Nord Expander
Schwarz Appliances
Band and Loop Space Maintainer
Sagittal Appliances
Hayrake -- Palatal with Spurs
Proactive (Spring Retainer)
EZ Bond Retainer
PhD Appliance
Tracey/Hilgers MDA Appliance
Cetlin Lip Bumper
Palatal Thumb Crib
Hawley Retainer
Spring Retainer
Wilson 3-D Appliance
Twin Block
Orthodontic Appliance and Parts
Haas Expander
Lower Expander
Upper or Lower Removable Quad
Acrylic Bonded RPE
Rachet Expander
Arnold Expander
Rapid Palatal Expander
Spring Jet Expanders
Porter Arch
Red, White, & Blue Retainer
SIMPLI5
Intrusion Splint
Silicone Positioner (Pro-Flex)
Mora/Gelb Splint
Bruxism Splint
Bleaching Trays
Flat Plane Splint
Damon Retention Splint
Repositioning Splint
Starnes Orthotic Appliance
AOB Splint
Herbst Appliance Acrylic Splint
Impak Positioner
Elast-Acryl
Flexiclear
Pro-Flex
Impak
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility