Not currently registered with FDA under this name
Majestic Drug Co., Inc.
Orange, CT, United States. Named as applicant on 3 dental 510(k) clearances between 1982 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31982–2010
- Markets registered in
- 25 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Majestic Drug Co., Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Majestic Drug Co., Inc. | 3 clearances | 1982–2010 | Below |
| Canada | Health Canada | Registration holder | MAJESTIC DRUG CO., INC. | 5 | 1999–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Majestic Drug Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Sep 2010 | K101771 | RELINE-IT MODEL RELINE-IT | EBP Over the Counter Denture Reliner |
| 21 Feb 1997 | K964773 | DENTEMP ONE STEP | EMA Dental Cement |
| 14 Jun 1982 | K821581 | DEN TEMP | EMB Zinc Oxide Eugenol |
Some of these clearances are listed with FDA today by another company: DOC BRANDS, Inc. (3).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.