THERMAPREP PLUS OVEN

K970134 · Tulsa Dental Products, Ltd. · EKM · Mar 21, 1997 · Dental

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

Indications for 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)

Submission Summary (Full Text)

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TULSA DENTAL PRODUCTS

Shaping The Future of Endodontics™

K970134

# 510(k) SUMMARY

Page 1 of 1

MAR 21 1997

ADDRESS: 5001 East 68th Street
Tulsa, OK 74136
[phone]
Telefax [phone]

CONTACT: Russell Vanderslice
DATE PREPARED: January 9, 1997

TRADE NAME: THERMAPREP® PLUS OVEN

CLASSIFICATION NAME: Accessory to Gutta Percha 21 CFR, 872.3850

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.

INTENDED USE: The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.

TECHNOLOGICAL CHARACTERISTICS: The predicate device, ThermaPrep® 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.

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