Data / Medical devices / United States / TBS Dental LLC
TBS Dental LLC: FDA-registered device maker in Dallas, TX, United States, 7 510(k) clearances
TBS Dental LLC is registered with the FDA (registration 3012101664) in Dallas, TX, United States. It lists 60 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012101664
- Address
- 2307 Springlake Rd Ste 518, Dallas, TX, United States, 75234
- Owner or operator
- TBS Dental (10050617)
- Roles
- Repackager or relabeler
- First device listed
- February 8, 2016
- Registered through
- 2026
- Brand names listed
- Dental Drill, PTFE Membrane, PTFE Suture, SHIELD ACCESSORY, SHIELDS, SHIELDVAC, Surgical Apparel Accessory, TBS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Retractor, Dental | EIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Articulators | EJP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Barrier, Synthetic, Intraoral | NPK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carver, Dental Amalgam, Operative | EKH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Operative | EKE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Collar And Crown | EIR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | 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 11, 2023 | K222549 | OpenTex | NPK | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| July 16, 2019 | K180992 | Biotex | NBY | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| June 9, 2008 | K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| June 3, 2005 | K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | GAP | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| June 3, 2005 | K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| June 2, 2005 | K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | GAR | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| April 8, 2005 | K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE | GAM | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Needle; Orthopedic
- All makers of Frame, Rubber Dam
- All makers of Plugger, Root Canal, Endodontic
- All makers of Tray, Impression, Preformed
- All makers of Forceps, Rongeur, Surgical
- All makers of Carrier, Amalgam, Operative
Updated May 11, 2023. 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.