THERMAPREP PLUS OVEN
Device Facts
| Record ID | K970134 |
|---|---|
| Device Name | THERMAPREP PLUS OVEN |
| Applicant | Tulsa Dental Products, Ltd. |
| Product Code | EKM · Dental |
| Decision Date | Mar 21, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3850 |
| Device Class | Class 1 |
Intended Use
The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.
Device Story
Heating unit for ThermaFil® endodontic obturators; utilizes microwave technology to achieve uniform, predictable heating; replaces radiant heat method of predicate; operated in clinical setting by dental professionals; reduces heating times for various obturator sizes; facilitates endodontic obturation procedures.
Clinical Evidence
Bench testing only. Comparison of heating times for various sizes of ThermaFil® endodontic obturators between subject device and predicate (K910224) demonstrated reduced heating times for the subject device.
Technological Characteristics
Heating unit for endodontic obturators; microwave-based heating principle; replaces radiant heat technology; standalone device.
Indications for Use
Indicated for heating ThermaFil® endodontic obturators for use in endodontic procedures.
Regulatory Classification
Identification
Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.
Predicate Devices
- ThermaPrep® Oven (K910224)
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