Data / Medical devices / United States / Keystone Industries
Keystone Industries: FDA-registered device maker in Cherry Hill, NJ, United States, 6 510(k) clearances
Keystone Industries is registered with the FDA (registration 2280629) in Cherry Hill, NJ, United States. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2280629
- FEI number
- 1000121639
- Address
- 616 Hollywood Ave, Cherry Hill, NJ, United States, 08002
- Owner or operator
- Keystone Industries (9007845)
- Roles
- Manufacturer
- First device listed
- December 26, 1995
- Registered through
- 2026
- Brand names listed
- Bosworth Zinc Phosphate Cement, Diamond D Denture Material, Duz-All, Fastray Custom Tray Material, KeyDenture Base, KeyDenture Try-In, KeyGuide, KeyPrint KeySplint Hard and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2024 | K241089 | KeyPrint KeyDenture Base | EBI | Substantially Equivalent | Keystone Industries | accessdata.fda.gov |
| April 9, 2021 | K203000 | KeyPrint KeySplint Hard | MQC | Substantially Equivalent | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | accessdata.fda.gov |
| November 15, 2019 | K183598 | KeyPrint KeySplint Soft | MQC | Substantially Equivalent | Keystone Industries | accessdata.fda.gov |
| September 23, 2003 | K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC | EBI | Substantially Equivalent | Mycone Dental Supply Co., Inc. | accessdata.fda.gov |
| November 14, 2001 | K012882 | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 | EBI | Substantially Equivalent | Thermoelastic Technologies, Inc. | accessdata.fda.gov |
| December 16, 1998 | K983876 | MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC | EBI | Substantially Equivalent | Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Mouthguard, Prescription
- All makers of Positioner, Tooth, Preformed
- All makers of Cement, Dental
- All makers of Indirect Bonding Tray
- All makers of Material, Impression Tray, Resin
Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.