(50 days)
The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.
This document is a 510(k) summary for the Obtura Heated Gutta Percha System and its FDA clearance letter. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.
The 510(k) process is primarily a premarket notification mechanism to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not require clinical trials or studies proving specific performance metrics against pre-defined acceptance criteria, especially for Class I or II devices like this one.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone (algorithm-only) performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the device is "an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide" and that it "has the same technological characteristics" as the predicate device, with electronics updated "to comply with current standards and regulations," and materials/design selected for "better aesthetics and asepsis." This indicates a focus on equivalence and regulatory compliance rather than novel performance claims requiring new clinical evidence.
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| II. | DEC - 1 2004510(K) Summary | K042828 |
|---|---|---|
| Submitted by: | Young OS LLCObtura Spartan1663 Fenton Business Park Ct.Fenton, Missouri 63026(636) 343-8300 | |
| Contact Person: | Stephen W. Conger, Jr. | |
| Date Prepared: | September 22, 2004 | |
| Proprietary Name: | Obtura | |
| Common name: | Obtura Heated Gutta Percha System | |
| Classification Name: | Instrument, Filling, Plastic, Dental | |
| Predicate Device: | Heated Gutta Percha System510(k) #K832654and/orElements Obturation Unit510(k) #K031664 |
Description of the Device: The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.
Intended Use of the Device: The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Technological Characteristics:
This device has the same technological characteristics and the predicate Obtura device and is operated by the user in the same fashion. The electronics have been update to comply with current standards and regulations, and the materials and design were selected for better aesthetics and asepsis.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
Mr. Stephen W. Conger Executive Vice President Young OS LLC 1663 Fenton Business Park Court Fenton, Missouri 63026
Re: K042828
K042020
Trade/Device Name: Obtura Heated Gutta Percha System Regulation Number: 872.4562 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EKR Dated: October 7, 2004 Received: October 12, 2004
Dear Mr. Conger:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to ria, 20, 1970, 1970, 1970, 1970, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999 Amelluments, or to devroos that natio e Act (Act) that do not require approval of a premarket the Federal Pood, Drug, und Cosment 1 to e-forapproval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the Pict. "The gains of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into exactives. Existing major regulations affecting (PMA), if may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
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Page 2 - Mr. Conger
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled of a base our device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and reguirements, including, but not limited to: registration You must comply with an the Pice oreq 21 CFR Part 801); good manufacturing practice and listing (21 CFR I art 607), laboling (21 CFR Pat 82), and if a
requirements as set forth in the quality systems (QS) regulation (21 CFR Partity of the A requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marieting your substantial equivalence of your device to a premarket nonication. "The PDA miams of cassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miremis, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Puarez
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement VI.
510(K) Number: | 042828
Device Name: Obtura Heated Gutta Percha System
Indications for Use: The Obtura is intended for use by professionally qualified indications for OSC. The Obtard to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR §801 Subpart D) OR
Over-The Counter Use (21 CFR 807 Subpart C
Cink D. thmer for MSR
(Division Sıgn-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number _ LD42823
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.