SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200

K091533 · Garrison Dental Solutions · JEP · Aug 17, 2009 · Dental

Device Facts

• Record ID: K091533
• Device Name: SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
• Applicant: Garrison Dental Solutions
• Product Code: JEP · Dental
• Decision Date: Aug 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1

Intended Use

The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.

Device Story

Slicks Matrix Bands and Sectional Matrix Bands are dental instruments used to retain composite or amalgam restorative materials during dental procedures. The bands surround the tooth to provide a gingival seal and facilitate tooth separation. Dentists select bands based on tooth height and restoration type; a wedge and ring retainer (e.g., Composi-Tight 3D Ring) are used to hold the band in place. The device is available in various thicknesses, lengths, and widths, and in soft or hard stainless steel. The primary feature is a proprietary coating. The band is removed after the composite resin is applied. Used in clinical dental settings by dentists.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 and performance testing to measure shear force were performed to validate the device, including the proprietary coating.

Technological Characteristics

Materials: soft or hard stainless steel with proprietary coating. Form factor: sectional or standard (Tofflemire) matrix bands. Function: mechanical retention of restorative materials. No energy source or software.

Indications for Use

Indicated for use in dental patients requiring composite or amalgam restorations to retain restorative materials and facilitate tooth separation and contouring.

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

• Garrison Composi-Tight Sectional matrix bands
• Waterpik Tofflemire bands
• Young Dental Ho bands
• Danville Sectional Matrix Bands

Submission Summary (Full Text)

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K091533

Image /page/0/Picture/1 description: The image shows the text "Garrison Dental Solutions" in a stylized font. The text is white and appears to have a textured or speckled effect, giving it a slightly rough or distressed look. The background is black, which makes the white text stand out prominently. The words are stacked, with "Garrison" on top and "Dental Solutions" underneath.

AUG 1 7 2009

# 510(k) Summary (as required by 21 CFR 807.92(c))

Date Prepared: 5/15/2009

# Regulatory Contact for Submission:

Joseph Azary Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: [phone] Fax: [phone] Email: [e-mail]

NOTE: Please send all correspondence regarding this 510(k) submission to Joseph Azary (at the above address).

## Manufacturer:

Garrison Dental Solutions 150 Dewitt Lane Spring Lake, MI 49456 [phone] Contact Name: Clarke Reberq

# FDA Establishment Registration: 1836088

161

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### Name of Device

- . Slicks Sectional Matrix Bands
- . Slicks Matrix Bands

# Classification Name

Dental Matrix Band, Sectional Matrix Band, Matrix Band (Tofflemire)

Class: Class 1

## Medical Specialty (Panel Code): Dental

Product Code: JEP

Regulation Number (CFR Section) 21 CFR 872.4565

## Identification of Predicate Device

The predicate devices identified for Slicks Matrix Bands are identified as follows:

- Garrison Composi-Tight Sectional matrix bands Class 1, 510k . exempt
- Waterpik Tofflemire bands Class 1, 510k exempt ●
- Young Dental Ho bands Class 1, 510k exempt .
- . Danville Sectional Matrix Bands - Class 1, 510k exempt

## Description of the Device

Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed.

The type of band is selected based on the tooth height and restoration type.

The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation.

A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place.

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We believe the wedge and G Ring would be class 1 dental instruments and not subject to 510(k).

The band is removed after the application of composite resin.

The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist.

The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.

### Intended Use

The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations,

## Comparison to Predicate Device

The main difference between the subject devices and the predicate devices are with regards to the proprietary coating of the subject devices. Non-Clinical Tests Performed

The device was subjected to and successfully passed biocompatibility testing per ISO 10993, as well as performance testing to measure shear force.

#### Technological Characteristics

The subject device has passed biocompatibility and shear force testing. These types of devices are typically class 1 exempt from 510(k). We have submitted this 510(k) because the devices are coated with proprietary coating.

#### Summarv

We believe the subject devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is an emblem that appears to be an eagle with its wings spread, though the image quality is poor and the details are not clear. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# AUG 1 7 2009

Garrison Dental Solutions i C/O Mr. Joseph Azary Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484

Re: K091533

Trade/Device Name: Slicks Matrix Bands and Sectional Matrix Bands Regulation Number: 21 CFR 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: JEP Dated: May 21, 2009 Received: May 26, 2009

Dear Mr. Azary:

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. În addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Azary

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,
Susan Runner

Susan Runner, D.D.S., M.A. Acting 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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510(k) Number (if known):

K091533

Device Name: Slicks Matrix Bands & Sectional Matrix Bands

The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.

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Concurrence of CDRH Office of Device Evaluation (ODE) ...

Over-The-Counter Use Prescription Use OR X (Per 21 CFR 801.109) (Optional Format 1-2-96) ್ಗ (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 510(k) Number: