Manufacturer registered with FDA
DOC BRANDS, Inc.
Wayne, PA, United States. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 21
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name DOC BRANDS, 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 | Manufacturer | DOC BRANDS, Inc. | 10 device types | — | Below |
| Brazil | ANVISA | Manufacturer | DOC BRANDS, INC. | 4 | 2020–2020 | 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
Devices listed with FDA
What DOC BRANDS, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | Reline-ItSof-Grip | 2018 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Dentemp Recap-ItRecap-ItRefil-It | 2018 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Dental CementDentempTemp-Fil | 2018 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Dentemp SleepTightSleepEasy MouthguardSleepEasy MouthpieceSleepTightSleepTight MouthpieceSleepTight Mouthpiece Rx | 2022 |
| Denture Repair KitEBO · Class 2 | — | Maker | Repair-It | 2018 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Clean-It | 2018 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Denture BrushInterdental Brush | 2019 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Dentemp Professional Oral Care Kit | 2018 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | ProxiPlusSwordFloss | 2018 |
| Tongue ScraperLCN · Class 1 | — | Maker | — | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DOC BRANDS, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Majestic Drug Co., Inc. (3), Michael D Williams Dds PA (2), Advanced Healthcare , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Dec 2019 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | LRK Anti-Snoring Device |
| 29 May 2014 | K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY | Michael D Williams Dds PA | LRK Anti-Snoring Device |
| 20 Sep 2010 | K101771 | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. | EBP Over the Counter Denture Reliner |
| 21 Mar 2003 | K024287 | FIXOBRIDGE 3-CEMENT | Advanced Healthcare , Ltd. | EMA Dental Cement |
| 21 Feb 1997 | K964773 | DENTEMP ONE STEP | Majestic Drug Co., Inc. | EMA Dental Cement |
| 14 Jun 1982 | K821581 | DEN TEMP | Majestic Drug Co., Inc. | EMB Zinc Oxide Eugenol |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DOC BRANDS, INC.FDA reg. 3015128224 | Knoxville, TN, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058144). 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.