(83 days)
Garrison Composi-Tight Sectional matrix bands, Waterpik Tofflemire bands, Young Dental Ho bands, Danville Sectional Matrix Bands
Not Found
No
The description details a physical dental device (matrix bands) and its use in a manual procedure. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a matrix band used to retain restorative materials during dental procedures. It does not actively treat or mitigate a disease or condition; rather, it's a tool that assists in the restoration process.
No
This device, a matrix band, is used to retain restorative materials during dental procedures. It does not diagnose any condition or provide diagnostic information.
No
The device description clearly describes physical matrix bands made of stainless steel, which are hardware components used in dental procedures. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retain composite or amalgam restorative materials during dental restorations." This is a mechanical function performed directly on the tooth within the patient's mouth.
- Device Description: The description details a physical matrix band used to shape and hold restorative materials during a dental procedure. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
- Performing tests outside of the body (in vitro)
The device is a tool used in a dental procedure to facilitate the placement of restorative materials. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
Product codes
JEP
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was subjected to and successfully passed biocompatibility testing per ISO 10993, as well as performance testing to measure shear force.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Garrison Composi-Tight Sectional matrix bands, Waterpik Tofflemire bands, Young Dental Ho bands, Danville Sectional Matrix Bands
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com
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 (616) 842-2244 Contact Name: Clarke Reberq
FDA Establishment Registration: 1836088
161
1
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.
2
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.
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
5
510(k) Number (if known):
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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: