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Sign in to claim this brandTULSA DENTAL PRODUCTS LLC
US
Last updated September 17, 2026
What TULSA DENTAL PRODUCTS LLC makes
The company manufactures single-use and reusable endodontic files and rasps for manual and rotary/reciprocating use, including nickel-titanium (NITI) instruments. It also produces synthetic gutta-percha, endodontic paper points, warm-bonded obturation systems, and single-use dental syringe needles. These products are designed for root canal treatment and related dental procedures.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, all listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tulsa Dental Products LLC manufacture?
Tulsa Dental Products LLC specializes in endodontic devices used primarily in root canal treatments. Their portfolio includes manual and rotary/reciprocating endodontic files and rasps, both single-use and reusable, such as nickel-titanium (NITI) instruments. They also produce synthetic gutta-percha for root canal filling, endodontic paper points, warm-bonded obturation system obturators, and single-use dental syringe needles. These products cater to various stages of endodontic procedures.
Where is Tulsa Dental Products LLC based?
Tulsa Dental Products LLC is based in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations, including FDA requirements.
Which regulatory registries list Tulsa Dental Products LLC’s devices?
Tulsa Dental Products LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes.
How are Tulsa Dental Products LLC’s devices classified under FDA regulations?
Tulsa Dental Products LLC’s devices fall into different FDA classification categories: Class I (generally low-risk devices), Class II (moderate-risk devices requiring special controls), and unclassified (U) devices. The classification depends on factors like the device’s intended use, risk level, and regulatory history, determining the level of oversight and requirements for market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 608 ROLLING HILLS DRIVE, Johnson City, TN, 37604
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1000554802
- DUNS Number
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Catalogue (3180)
Page 42 of 64| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProTaper Universal Rotary File | PTURF531 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 6319025 | FDA UDI | Class I | Active |
| Endodontic Obturators | 669151 | FDA UDI | Class I | Active |
| GT Obturator | GTOB20066 | FDA UDI | Class I | Active |
| Hedstrom-Files | 07325040R | FDA UDI | Class I | Active |
| Hedstrom-Files | 07331045R | FDA UDI | Class I | Active |
| Endodontic Absorbent Paper Points | 670197 | FDA UDI | Class I | Active |
| Lexicon | NT05025 | FDA UDI | Class I | Active |
| ProFile Orifice Opener | OS0119 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT062521 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT04A1521 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 6860027 | FDA UDI | Class I | Active |
| Vortex Blue Rotary File | VTB042521 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 7321010 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 86425020 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 671130 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 671120 | FDA UDI | Class I | Active |
| WaveOne Gold Treatment Covience Kit | T00W1G0TS0KIT | FDA UDI | Class I | Active |
| Lexicon | GP15ISOC120 | FDA UDI | Class I | Active |
| Radix Anchor | 671620 | FDA UDI | Class I | Active |
| GT Post Drills | GTS1D | FDA UDI | Class I | Active |
| TotalEndo | TEHF1031 | FDA UDI | Class I | Active |
| TotalEndo GATES Glidden drills | TEGG432 | FDA UDI | Class I | Active |
| ProFile Vortex Obturator | VX02526 | FDA UDI | Class I | Active |
| TRUShape | TSFILE2031 | FDA UDI | Class I | Active |
| GT Series X Absorbent Points | SXPP04 | FDA UDI | Class I | Active |
| Lexicon | SSK06025 | FDA UDI | Class I | Active |
| Lexicon | SSK03531 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT065021 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT042530 | FDA UDI | Class I | Active |
| K-Reamers | 05328165R | FDA UDI | Class I | Active |
| ProTaper Gold Rotary File | PTGRF521 | FDA UDI | Class I | Active |
| Hedstrom-Files | 07321050R | FDA UDI | Class I | Active |
| Lexicon | GPXLNC120 | FDA UDI | Class I | Active |
| Endodontic Obturators | 02523S | FDA UDI | Class I | Active |
| ProFile Vortx Rotary File | PFV062025 | FDA UDI | Class I | Active |
| Lexicon | GP0425 | FDA UDI | Class I | Active |
| ProTaper Universal Obturators 6-PK F1 | PTUOBF1 | FDA UDI | Class I | Active |
| ProTaper Next Rotary File | PTN | FDA UDI | Class I | Active |
| GT Files of Greater Taper | GT0802030 | FDA UDI | Class I | Active |
| BioPure | BPSYRNDL2 | FDA UDI | U | Active |
| K-file hand instrument | KFS01021 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 6325012 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT047030 | FDA UDI | Class I | Active |
| Lexicon | NT05021 | FDA UDI | Class I | Active |
| Reciproc Rotary Files | TSTRCP0631040 | FDA UDI | Class I | Active |
| ProFile NT Rotary File | PIT043530 | FDA UDI | Class I | Active |
| Endodontic Hand Instruments | 86331070 | FDA UDI | Class I | Active |
| Vortex Blue Rotary File | VTB042530 | FDA UDI | Class I | Active |
| Lexicon | GPXFNC120 | FDA UDI | Class I | Active |
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