(65 days)
No
The description focuses on microwave heating technology and does not mention AI or ML.
No
The device is a heating oven used to prepare therapeutic endodontic obturators before their use in treating endodontic issues, and is therefore a preparation device rather than a therapeutic device itself.
No
Explanation: The device is a heating unit for obturators and is not used to diagnose any medical condition.
No
The device description explicitly states it is a "heating unit" and uses "Microwave technology," indicating it is a hardware device.
Based on the provided information, the THERMAPREP® PLUS OVEN is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is specifically for heating endodontic obturators (ThermaFil®). This is a procedure performed on a patient (in vivo), not on a sample taken from a patient (in vitro).
- Device Description: The description confirms it's a heating unit for obturators, used in the context of endodontic procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the THERMAPREP® PLUS OVEN is a medical device used in a clinical setting for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.
Product codes
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Device Description
The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Various sizes of ThermaFil® endodontic obturators were heated using the THERMAPREP® PLUS OVEN and using the ThermaPrep Oven (K910224). Results showed that heating times for all sizes of obturators were greatly reduced using the THERMAPREP® PLUS OVEN.
Key Metrics
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Predicate Device(s)
ThermaPrep® Oven K910224
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3850 Gutta percha.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/0 description: The image shows the text "TULSA DENTAL PRODUCTS" in bold, black font. The text is stacked on a single line and appears to be a company name or product line. The font is sans-serif and the letters are closely spaced together.
Shaping The Future of Endodontics™
510(k) SUMMARY
Page 1 of 1
ADDRESS: 5001 East 68th Street Tulsa, OK 74136 (918) 493-6598 Telefax (918) 493-6599
MAR 2 1 1997
DATE PREPARED: January 9, 1997 CONTACT : Russell Vanderslice
THERMAPREP® PLUS OVEN TRADE NAME :
21 CFR, 872.3850 Accessory to Gutta Percha CLASSIFICATION NAME:
PREDICATE DEVICE: ThermaPrep® Oven K910224
DEVICE DESCRIPTION: The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.
The THERMAPREP® PLUS OVEN is specially developed for heating INTENDED USE: ThermaFil® endodontic obturators. Do not use the oven for any other purpose.
ThermaPrep® TECHNOLOGICAL CHARACTERISTICS: The predicate device, Oven (K910224), heats ThermaFil® endodontic obturators by radiant heat. The new THERMAPREP® PLUS OVEN performs the same function by using microwave technology.
Various sizes of ThermaFil® endodontic obturators were heated using the THERMAPREP® PLUS OVEN and using the ThermaPrep Oven (K910224). Results showed that heating times for all sizes of obturators were greatly reduced using the THERMAPREP® PLUS OVEN.
We believe that the performance data demonstrates the safety and effectiveness of the THERMAPREP® PLUS OVEN for its intended use.