Thermafil Endodontic Obturator
FDA 510(k) K900986 · Tulsa Dental Products, Ltd.
510(k) numberK900986
Submission
- Device name
- Thermafil Endodontic Obturator
- Applicant
- Tulsa Dental Products, Ltd.
Tulsa, OK, US - Received
- March 1, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073369 | Ei Downpak Barrier SleevesEKM · Traditional | Hu-Friedy Mfg. Co., Inc. | 02/27/2008SE |
| K070246 | Down PakEKM · Special | Endo Twinn B.V. | 02/16/2007SE |
| K051573 | TGP (Gutta Percha Containing Tetracycline or Doxycycline)EKM · Traditional | Dr. Howard Martin, P.A. | 06/26/2006SE |
| K042870 | Endo TwinnEKM · Traditional | Endo Twinn B.V. | 01/11/2005SE |
| K023819 | Fiberfill SGPEKM · Traditional | Pentron Clinical Technologies | 03/26/2003SE |
| K971641 | Antibacterial Gutta PerchaEKM · Traditional | Dr. Howard Martin, P.A. | 07/21/1997SE |
| K970134 | Thermaprep Plus OvenEKM · Traditional | Tulsa Dental Products, Ltd. | 03/21/1997SE |
| K931742 | Inject-R FillEKM · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/27/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | Unicep | 03/05/1993SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | Analytic Technology | 01/21/1992SE |
More from Analytic Technology
| 510(k) | Device | Decision |
|---|---|---|
| K970134 | Thermaprep Plus OvenEKM · Traditional | 03/21/1997SE |
| K964174 | Mineral Trioxide Aggregate (Mta)KIF · Traditional | 02/10/1997SE |
| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | 01/16/1996SE |
| K922931 | Thermapost Endodontic Root Canal PostELR · Traditional | 05/26/1994SE |
| K933582 | Profile Series 29 FilesEKS · Traditional | 10/20/1993SE |
| K910224 | ThermaprepEKM · Traditional | 03/29/1991SE |
| K881139 | Thermafil Endodontic ObturatorEKM · Traditional | 04/07/1988SE |
Questions and answers
When was Thermafil Endodontic Obturator cleared by the FDA?
Thermafil Endodontic Obturator (K900986) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 257 days after the submission was received.
What is the product code of K900986?
The FDA product code is EKM – Gutta-Percha, a Class I (low risk) device regulated under 21 CFR 872.3850.