FDA Registration
Active
🇺🇸 United States
Keystone Industries
Reg #: 2280629
·
FEI: 1000121639
·
Expires 2026
Products
8
Proprietary Names
28
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Keystone Industries
- Registration Number
- 2280629
- FEI Number
- 1000121639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 616 Hollywood Ave
- City
- CHERRY HILL
- State
- NJ
- ZIP
- 08002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012882
Owner / Operator
- Firm Name
- Keystone Industries
- Operator Number
- 9007845
- Address
- 480 S. Democrat Road, --
- City
- Gibbstown
- State
- NJ
- Postal Code
- 08027
- Country
- US
- Correspondent
- Gloria - Zuclich
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2011-10-24 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2021-04-14 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2021-04-14 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2016-01-21 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2020-08-28 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 1995-12-26 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-11-28 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-10-26 |
Proprietary Names
Versacryl Denture Material
KeyPrint KeySplint Hard
Trim II
Trim
KeyPrint® KeyOrtho IBT
Proform Blue Tray
Proform Pink Baseplate
Fastray Custom Tray Material
Proform ProSplint
Proform Splint
KeyTray
KeyDenture Try-In
Bosworth Zinc Phosphate Cement
Mizzy Fleck's Zinc Cement
Mizzy Polycarboxylate (PCA) Cement Powder
KeyDenture Base
Millennium
Sledgehammer
Original Truliner
Duz-All
TruRepair
Ultra Fast
Softone
Trusoft
New Truliner
Diamond D Denture Material
KeyGuide
KeySplint Soft
Establishment Types
Manufacture Medical Device