Data / Medical devices / United States / Doc Brands, Inc.
Doc Brands, Inc.: FDA-registered device maker in Knoxville, TN, United States, 9 510(k) clearances
Doc Brands, Inc. is registered with the FDA (registration 3015128224) in Knoxville, TN, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015128224
- Address
- 10334 Cogdill Rd, Knoxville, TN, United States, 37932
- Owner or operator
- DOC BRANDS, Inc. (10058144)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 17, 2018
- Registered through
- 2026
- Brand names listed
- Clean-It, Dental Cement, Dentemp, Dentemp Professional Oral Care Kit, Dentemp Recap-It, Dentemp SleepTight, Denture Brush, Grin Dental Guard and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Denture Repair Kit | EBO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 19, 2025 | K250456 | Dentemp Pro-Comfort Dental Guard | OBR | Substantially Equivalent | Doc Brands, Inc. | accessdata.fda.gov |
| October 7, 2022 | K222424 | Protect-It Custom Fit Dental Guard | OBR | Substantially Equivalent | Doc Brands, Inc. | accessdata.fda.gov |
| December 11, 2019 | K191618 | SleepTight Mouthpiece STZ | LRK | Substantially Equivalent | Michael D Williams Dds PA | accessdata.fda.gov |
| February 19, 2016 | K150492 | Ora-GUARD Dental Grind Guard | OBR | Substantially Equivalent | Bite Tech, Inc. | accessdata.fda.gov |
| May 29, 2014 | K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY | LRK | Substantially Equivalent | Michael D Williams Dds PA | accessdata.fda.gov |
| September 20, 2010 | K101771 | RELINE-IT MODEL RELINE-IT | EBP | Substantially Equivalent | Majestic Drug Co., Inc. | accessdata.fda.gov |
| March 21, 2003 | K024287 | FIXOBRIDGE 3-CEMENT | EMA | Substantially Equivalent | Advanced Healthcare , Ltd. | accessdata.fda.gov |
| February 21, 1997 | K964773 | DENTEMP ONE STEP | EMA | Substantially Equivalent | Majestic Drug Co., Inc. | accessdata.fda.gov |
| June 14, 1982 | K821581 | DEN TEMP | EMB | Substantially Equivalent | Majestic Drug Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Floss, Dental
- All makers of Cement, Dental
- All makers of Mouthguard, Over-The-Counter
- All makers of Denture Repair Kit
- All makers of Zinc Oxide Eugenol
- All makers of Handle, Instrument, Dental
Updated May 19, 2025. 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.