FDA Registration
Active
🇺🇸 United States
TULSA DENTAL PRODUCTS LLC
Reg #: 2320721
·
FEI: 1000554802
·
Expires 2026
Products
25
Proprietary Names
15
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- TULSA DENTAL PRODUCTS LLC
- Registration Number
- 2320721
- FEI Number
- 1000554802
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 608 ROLLING HILLS DRIVE
- City
- Johnson City
- State
- TN
- ZIP
- 37604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011009
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2008-01-28 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2008-01-28 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 1996-08-21 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1977-12-15 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2008-08-19 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2006-10-26 |
| Device, Caries Detection | LFC | Class 2 | Dental | No | 2012-01-09 |
| Point, Silver, Endodontic | EKL | Class 1 | Dental | No | 2012-01-09 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2018-12-04 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1977-12-15 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1984-11-16 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2008-03-13 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1998-09-08 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2017-03-17 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2017-03-17 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1997-06-27 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2012-01-09 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 1996-08-21 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 1992-08-24 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 1998-09-08 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-02-19 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2008-01-28 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1992-08-12 |
| File, Periodontic | EMR | Class 1 | Dental | No | 1998-09-08 |
| Endodontic Kit | NYD | Class 2 | Dental | No | 2022-08-31 |
Proprietary Names
ProRoot MTA, Tooth Colored Formula
BioPure MTAD Root Canal Cleanser
Caulk Post & Core Kit
Paper Points
Bracket Height Gauge
X-Tip Intraosseous Injection Sys
Root Canal Lube
Drills
GATES
LARGO
ProUltra Endo Tips
ProUltra Surgical
ProUltra SINE Tip
ProRoot MTA Matl (root repair)
ProRoot MTA
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility