Thermapost Endodontic Root Canal Post
FDA 510(k) K922931 · Tulsa Dental Products, Ltd.
510(k) numberK922931
Submission
- Device name
- Thermapost Endodontic Root Canal Post
- Applicant
- Tulsa Dental Products, Ltd.
Tulsa, OK, US - Received
- June 17, 1992
- Decision date
- May 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K970134 | Thermaprep Plus OvenEKM · Traditional | 03/21/1997SE |
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| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | 01/16/1996SE |
| K933582 | Profile Series 29 FilesEKS · Traditional | 10/20/1993SE |
| K910224 | ThermaprepEKM · Traditional | 03/29/1991SE |
| K900986 | Thermafil Endodontic ObturatorEKM · Traditional | 11/13/1990SE |
| K881139 | Thermafil Endodontic ObturatorEKM · Traditional | 04/07/1988SE |
Questions and answers
When was Thermapost Endodontic Root Canal Post cleared by the FDA?
Thermapost Endodontic Root Canal Post (K922931) received a 510(k) decision of Substantially Equivalent on May 26, 1994, 708 days after the submission was received.
What is the product code of K922931?
The FDA product code is ELR – Post, Root Canal, a Class I (low risk) device regulated under 21 CFR 872.3810.