TULSA DENTAL PRODUCTS LLC

FDA Device Registration & Listing · Johnson City, TN, US · Registration 2320721

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2320721
FEI Number
1000554802
Entity Name
TULSA DENTAL PRODUCTS LLC
City/State/Country
Johnson City, TN, US
Establishment Address
608 ROLLING HILLS DRIVE, Johnson City, TN 37604, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2008-01-28
KJJ Cleanser, Root Canal Unknown Class U N/A 2008-01-28
EKN Point, Paper, Endodontic Dental Class 1 872.3830 1996-08-21
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2009-05-13
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 1977-12-15
DZM Needle, Dental Dental Class 1 872.4730 2008-08-19
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2021-12-07
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 2006-10-26
LFC Device, Caries Detection Dental Class 2 872.1740 2012-01-09
EKL Point, Silver, Endodontic Dental Class 1 872.3840 2012-01-09
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-01-13
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2012-01-09
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2018-12-04
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 1977-12-15
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1984-11-16
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2008-03-13
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1998-09-08
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2017-03-17
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2017-03-17
EJL Bur, Dental Dental Class 1 872.3240 1997-06-27
EMA Cement, Dental Dental Class 2 872.3275 2012-01-09
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 1996-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27
K040153 Indigenous Peoples Technology and Education Center I-TEC PORTABLE DENTAL OPERATORY 2004-05-21
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2020 Inter-Med Llc U
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020 Inter-Med Llc U
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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1032227 BRASSELER U.S.A. DENTAL, LLC SAVANNAH, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2320721. Last updated year: 2026. Please use registration number 2320721 when referencing this establishment in official correspondence.
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