ELEMENTS OBTURATION UNIT

K031664 · Sybron Endo/Analytic · EKR · Apr 28, 2004 · Dental

Device Facts

• Record ID: K031664
• Device Name: ELEMENTS OBTURATION UNIT
• Applicant: Sybron Endo/Analytic
• Product Code: EKR · Dental
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the Elements Obturation Unit is to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and downpack gutta percha during endodontic root canal treatment. Additionally, when the unit is used in the Extruder Mode, the Elements Obturation Unit is used to backfill gutta percha during root canal obturation.

Device Story

Elements Obturation Unit is an AC-powered endodontic device; used by dentists in clinical settings. Device operates in two modes: System B (downpack/backfill gutta percha, thermal pulp testing, tissue cautery) and Extruder (backfill gutta percha). Microprocessor-controlled; features LCD screen and membrane switch controls. Handpieces are removable and autoclavable. Device supports network-style communication for data sharing between endodontic devices. Provides continuous heat at instrument tip; allows temperature adjustment. Extruder mode offers settings for gutta percha type (alpha/beta), extrusion speed, and alarm parameters. Assists clinicians in root canal obturation and diagnostic thermal testing; improves procedural efficiency and control during endodontic therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered endodontic unit; microprocessor-controlled. Features LCD screen, membrane switches, and removable/autoclavable handpieces. Supports network-style communication. Functions include thermal heating for gutta percha manipulation, pulp testing, and cautery. No specific material standards or software architecture details provided.

Indications for Use

Indicated for use in dentistry for patients undergoing endodontic root canal treatment or requiring thermal pulp testing, tissue cauterization, or coagulation.

Regulatory Classification

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.

Predicate Devices

• Sybron Endo/Analytic, System B HeatSource
• Obtura Spartan, Obtura II

Submission Summary (Full Text)

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APR 2 8 2004

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.

K031664

Section III - 510(k) Summary of Safety and Effectiveness

Submitter: Sybron Dental Specialties, Inc. 1717 West Collins Ave Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: May 2003

### Device Name:

- Trade Name Elements Obturation Unit .
- ◆ Common Name - Endodontic Obturation Unit
- Classification Name Pulp Tester, per 21 CFR § 872.1720

### Devices for Which Substantial Equivalence is Claimed:

- Sybron Endo/Analytic, System B HeatSource .
- Obtura Spartan, Obtura II .

### Device Description:

The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may sclect the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.

### Intended Use of the Device:

The intended use of the Elements Obturation Unit is to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and downpack gutta percha during endodontic root canal treatment. Additionally, when the unit is used in the Extruder Mode, the Elements Obturation Unit is used to backfill gutta percha during root canal obturation.

### Substantial Equivalence:

The Elements Obturation Unit is substantially equivalent to other legally marketed devices in the United States. The Elements Diagnostic Unit functions in a manner similar to and is intended for the same use as the System B HeatSource manufactured by Sybron Endo/Analytic and the Obtura II manufactured by Obtura Spartan. 1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing health, human services, and prevention. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

# APR 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sybron Dental Specialties, Incorporated Ms. Colleen Boswell Director, Corporate Compliance Division of Ormco Corporation 1717 West Collins Avenue Orange, California 92867

Re: K031664

Trade/Device Name: Elements Obturation Unit Regulation Number: 872.4562 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EKR Dated: March 2, 2004 Received: March 3, 2004

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or me ret or mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instille (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as bettronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Oure

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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K031664

## Indications for Use

510(k) Number (if known): K031664

Device Name: Elements Obturation Unit

Indications For Use:

The Elements Obturation Unit is intended to be used in Dentistry to:

- 1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
- 2. For tissue cauterization and coagulation, and
- 3. To backfill and downpack gutta percha during Endodontic root canal treatment.
- 4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.E. adu Fa, MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental D

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510(k) Number: K031664