Data / Medical devices / United States / Tulsa Dental Products LLC
Tulsa Dental Products LLC: FDA-registered device maker in Johnson City, TN, United States, 18 510(k) clearances
Tulsa Dental Products LLC is registered with the FDA (registration 2320721) in Johnson City, TN, United States. It lists 25 device types. The FDA files 18 510(k) clearances under its listings, the newest dated February 26, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2320721
- FEI number
- 1000554802
- Address
- 608 Rolling Hills Drive, Johnson City, TN, United States, 37604
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 15, 1977
- Registered through
- 2026
- Brand names listed
- BioPure MTAD Root Canal Cleanser, Bracket Height Gauge, Caulk Post & Core Kit, Drills, GATES, LARGO, Paper Points, ProRoot MTA and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| February 26, 2018 | K170175 | ENDOSEAL MTA | KIF | Substantially Equivalent | Maruchi | accessdata.fda.gov |
| February 10, 2017 | K161213 | XSmart iQ | EBW | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| February 26, 2015 | K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | KIF | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| February 14, 2011 | K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | KJJ | Substantially Equivalent | Dentsply Intl., Inc. | accessdata.fda.gov |
| December 8, 2005 | K053167 | BIOPURE MTAD ROOT CANAL CLEANSER | KJJ | Substantially Equivalent | Dentsply Intl., Inc. | accessdata.fda.gov |
| May 2, 2001 | K011009 | WHITE MTA MATERIAL | KIF | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| February 14, 2001 | K010012 | LC PROVIFILL | EBG | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| April 27, 1999 | K990511 | X-TIP INTRAOSSEOUS PERFORATOR | DZM | Substantially Equivalent | Schiff & Co. | accessdata.fda.gov |
| December 10, 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB | Substantially Equivalent | Bien Air USA, Inc. | accessdata.fda.gov |
| July 31, 1998 | K981620 | MTA MATERIAL II | KIF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 24, 1998 | K980332 | MTA MATERIAL | KIF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 30, 1997 | K972234 | RCT GEL ROOT CANAL THERAPY GEL | EIC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 10, 1997 | K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | KIF | Substantially Equivalent | Tulsa Dental Products, Ltd. | accessdata.fda.gov |
| January 17, 1997 | K964430 | PULPDENT SNOOP | LFC | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| May 10, 1996 | K960889 | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS | ELC | Substantially Equivalent | San Diego Swiss Machining, Inc. | accessdata.fda.gov |
| April 23, 1996 | K961089 | PULPDENT ENDOPREP II | EKL | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| July 19, 1995 | K952960 | PULPDENT POST CEMENT | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 20, 1993 | K932791 | PULPDENT EDTA PREPARATIONS | KIF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Pulp Canal, Endodontic
- All makers of Device, Caries Detection
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- All makers of Resin, Root Canal Filling
- All makers of Bur, Dental
Updated February 26, 2018. 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.