FDA Registration
Active
🇺🇸 United States
TBS Dental LLC
Reg #: 3012101664
·
FEI: 3012101664
·
Expires 2026
Products
60
Proprietary Names
12
Establishment Types
1
Classifications
60
Registration Details
- Registration Name
- TBS Dental LLC
- Registration Number
- 3012101664
- FEI Number
- 3012101664
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2307 Springlake Rd Ste 518
- City
- Dallas
- State
- TX
- ZIP
- 75234
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041514
Owner / Operator
- Firm Name
- TBS Dental
- Operator Number
- 10050617
- Address
- 2307 Springlake Rd Ste 518
- City
- Dallas
- State
- TX
- Postal Code
- 75234
- Country
- US
- Correspondent
- Haseeb Sajid
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2016-09-28 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2016-09-28 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2019-07-10 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2016-09-28 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2025-06-16 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2016-09-28 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2019-07-10 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2016-09-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-07-10 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2019-07-10 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2016-09-28 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2016-09-28 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2016-09-28 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2019-07-10 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2025-06-16 |
| Articulators | EJP | Class 1 | Dental | No | 2016-09-28 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2025-06-16 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2021-08-27 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2016-09-28 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2019-07-10 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2016-09-28 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-06-08 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2016-09-28 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2016-09-28 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2016-09-28 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2025-03-12 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2016-09-28 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2016-09-28 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2019-07-10 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-09-28 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2026-06-20 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2016-05-29 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2016-09-28 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2016-09-28 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2019-07-10 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2022-04-11 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2016-05-29 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2016-09-28 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2016-05-29 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2016-09-28 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2016-02-08 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2016-09-28 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2016-09-28 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2016-09-28 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2019-07-10 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2016-02-08 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2016-09-28 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2016-05-30 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2016-09-28 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-04-17 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2019-07-10 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2016-02-08 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2016-09-28 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2016-09-28 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2016-02-08 |
| Curette, Operative | EKE | Class 1 | Dental | No | 2016-09-28 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2016-09-28 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2025-03-12 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2025-06-16 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2016-09-28 |
Proprietary Names
TBS INOX USA
TBS INOX
TBS
Dental Drill
Universal Shapers
SHIELDVAC
Surgical Apparel Accessory
PTFE Membrane
TBS BIO
SHIELD ACCESSORY
SHIELDS
PTFE Suture
Establishment Types
Repack or Relabel Medical Device