FDA Registration
Active
🇺🇸 United States
WHITE OAK ORTHODONTIC PRODUCTS
Reg #: 3009827000
·
FEI: 3009827000
·
Expires 2026
Products
22
Proprietary Names
13
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- WHITE OAK ORTHODONTIC PRODUCTS
- Registration Number
- 3009827000
- FEI Number
- 3009827000
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 330 E Main St
- City
- Mount Joy
- State
- PA
- ZIP
- 17552
- Country
- US
Regulatory Submissions
- 510(k) Number
- K922499
Owner / Operator
- Firm Name
- White Oak Orthodontic Products
- Operator Number
- 10042063
- Address
- 330 East Main Street
- City
- Mount Joy
- State
- PA
- Postal Code
- 17552
- Country
- US
- Correspondent
- JAMES I HESLOP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2012-10-15 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2012-10-15 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2012-10-15 |
| Protractor | HTH | Class 1 | Orthopedic | No | 2012-10-16 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2012-10-16 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2012-10-15 |
| Floss, Dental | JES | Class 1 | Dental | No | 2012-10-15 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2012-10-15 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2012-10-15 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-10-15 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2012-10-15 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2016-10-17 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2012-10-16 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2012-10-15 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2012-10-15 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2012-10-17 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2012-10-15 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-10-15 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2012-10-16 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2012-10-15 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2012-10-16 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2012-10-15 |
Proprietary Names
Infinity
Innova
Integrity
Halo
Ghost
Novis
meridian
vortex
MACHI
MACHII
Lux V-Slot
Quantum
WOOP
Establishment Types
Repack or Relabel Medical Device