FDA Registration
Active
🇺🇸 United States
Keystone Industries - Gibbstown
Reg #: 3010002722
·
FEI: 3010002722
·
Expires 2026
Products
17
Proprietary Names
49
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- Keystone Industries - Gibbstown
- Registration Number
- 3010002722
- FEI Number
- 3010002722
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 480 S Democrat Rd
- City
- Gibbstown
- State
- NJ
- ZIP
- 08027
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030859
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 |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2014-10-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2007-11-28 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2019-11-15 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2019-11-15 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2015-12-14 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2015-12-14 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2016-01-21 |
| Adhesive, Denture, Karaya | KOP | Class 1 | Dental | No | 2015-12-14 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-10-26 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2016-01-21 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2010-12-01 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2020-08-28 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2008-11-12 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2012-01-09 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2012-05-31 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 1995-12-26 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2015-12-10 |
Proprietary Names
Enamelite Ceramic Spray Glaze
Diamond D Denture Material
KeySplint Soft
Copaliner
Dentusil
Bosworth Pit & Fissure Sealant with Fluoride
Trim II
Trim
Keymill
Cora-Caine
KeyGuide
Optimize General Purpose Ultrasonic Cleaner-Liquid
Optimize Tartar, Stain & Permanent Cement Remover Ultrasonic Powder
Optimize General Purpose Ultrasonic Cleaner-Powder
Optimize Tartar, Stain & permanent Cement Remover Ultrasonic Liquid
Optimize Refresh Enzymatic Ultrasonic Instrument Cleaner
KeyDenture Base
Bosworth Prophy Powder
KeyPrint® KeyOrtho IBT
Versacryl sealant
Millennium
Sledgehammer
Original Truliner
Duz-All
TruRepair
Ultra Fast
Softone
Trusoft
New Truliner
Seity Etchant Gel
Bosworth Acid Etch
KeyPrint KeySplint Hard
Edentulous Impression Trays
Stainless Steel Trays
Prehma Multi Bite Impression Trays
Tray Aways Disposable Impression trays
Big Bite Trays
BoTrays disposable impression trays
Tray Adhesive Compound(TAC) Liquid and Spray
Prehma Disposable Impression Trays
Proform Blue Tray
Proform Pink Baseplate
Fastray Custom Tray Material
Proform ProSplint
Proform Splint
KeyTray
KeyDenture Try-In
Versacryl Denture Material
SuperEBA
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)