(141 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical abrasion for surface preparation in dental procedures. There is no mention of AI or ML in the text.
No
The device is used for surface preparation in dentistry, such as for bonding, repairs, and cementation, which are procedural steps rather than directly treating a medical condition.
No
The device description, intended use, and performance studies all indicate that the ACCU-PREP is used for preparing surfaces in dental procedures (e.g., bonding, repair, cementation), not for diagnosing medical conditions.
No
The device description explicitly mentions "handpiece" and describes physical components like an "abrasive reservoir," indicating it is a hardware device that uses abrasive material for surface preparation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to preparing surfaces of dental materials (metal, porcelain, composite, acrylic) and tooth structure for bonding or repair. These are mechanical procedures performed directly on or in the patient's mouth.
- Device Description: The device is described as operating with air pressure to abrade surfaces. This is a physical process, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is a tool for preparing surfaces for dental procedures.
- Anatomical Site: The anatomical sites mentioned are intra-oral, prepared tooth, and tooth structure, which are consistent with dental procedures, not in vitro diagnostics.
- Performance Studies: The performance studies described are shear bond tests and Scanning Electron Microscopy of abraded surfaces, which evaluate the device's effectiveness in preparing surfaces for bonding, not its diagnostic accuracy.
In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
ACCU-PREP is intended to be used to abrade and enhance the bond between the prepared tooth and cast dental metals for Maryland bridges, for cementation of cast metal restorations, for porcelain repair, as a porcelain etch substitute, to prepare indirect composite restorations for cementation, for repair of composite or resin restorations, repair of acrylic facings on cast restorations, endodontic post preparation, denture repairs, and orthodontic applications such as: preparation of brackets to enhance bonding, cement removal from brackets, and enhancement of adhesion to tooth structure.
Indications for Use:.
-
- Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
-
- Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
-
- Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
- Porcelain etch substitute: for preparation of intaglio surface of porcelain 4. restorations in place of etching with hydrofluoric acid in the mouth.
-
- Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
-
- Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
-
- Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
-
- Endodontic post preparation : for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
- Denture repairs: for preparation of denture base to facilitate repairs. 9.
-
- Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before rebonding. For enhancement of adhesive to tooth structure.
Product codes (comma separated list FDA assigned to the subject device)
KOJ
Device Description
ACCU-PREP is virtually identical to the MICROETCHER in design and function. The two models of the device, Type I and Type II are identical in design and function but differ cosmetically. That is Type I is nearly identical to the MICROETCHER and Type II is esthetically more pleasing. In addition, Type II has the abrasive reservoir in the center of the handpiece as opposed to the back end as in the MICROETCHER and it is completely autoclavable. The ACCU-PREP operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60.
The scientific concepts of this device are basic. A relatively high velocity stream of compressed gas (air), when blown across the opening of a tube set at 90 degrees to the air stream creates a low pressure at the opposite end of the perpendicular tube. This low pressure (vacuum) sucks up an abrasive powder from a reservoir and propels the abrasive thereby abrading the surface of an object in its path. The phenomenon is analogous to a perfume bottle. The abrasive powder behaves as the perfume, that is, as air is blown across the opening the abrasive powder is blown into the air stream.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Comparison of ACCU-PREP to the predicate device shows both are very similar with the major difference being esthetics. The proposed new products, Types I and II, are functionally identical to the predicate device but are more esthetically acceptable top the patient as well as to the dentistry and dental auxiliary. One notable difference between the tow is the applicant device operates at lower air pressure.
Both employ 50 um aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 um
Since both devices are appear essentially identical their performances were compared by testing in actual use situations. Shear bond tests were performed on human extracted teeth using identical conditions with the only difference being the device abrading the substrate. No statistically significant difference was found in this test at p >= 0.05. Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MICROETCHER
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
JUL 1 1997
BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for ACCU-PREP™
510(k) SUMMARY
As Required by the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE MICROETCHER™
MICROETCHER is a compressed air driven dental sandblasting device intended for intra-oral use to roughen dental hard tissues or restorative materials to enhance bonding of resin materials. The device is a hand held instrument resembling a dental handpiece in shape and function. The unit is operated at 60-100 psig of compressed air. A venturi principle forces an abrasive, aluminum oxide (50um particle size), toward the object to be abraded. The high velocity abrasive imparts sufficient energy to abrade and remove material.
The device can be used extra-orally for similar purposes, that is, to roughen dental restorations to enhance bonding or to behave as a cleaning device.
DESCRIPTION OF APPLICANT DEVICE
ACCU-PREP™
ACCU-PREP is virtually identical to the MICROETCHER in design and function. The two models of the device, Type I and Type II are identical in design and function but differ cosmetically. That is Type I is nearly identical to the MICROETCHER and Type II is esthetically more pleasing. In addition, Type II has the abrasive reservoir in the center of the handpiece as opposed to the back end as in the MICROETCHER and it is completely autoclavable. The ACCU-PREP operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60.
INTENDED USES OF APPLICANT DEVICE
ACCU-PREP is intended to be used to abrade and enhance the bond between the prepared tooth and cast dental metals for Maryland bridges, for cementation of cast metal restorations, for porcelain repair, as a porcelain etch substitute, to prepare indirect composite restorations for cementation, for repair of composite or resin restorations, repair of acrylic facings on cast restorations, endodontic post preparation, denture repairs, and orthodontic applications such as: preparation of brackets to enhance bonding, cement removal from brackets, and enhancement of adhesion to tooth structure.
30
1
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
The scientific concepts of this device are basic. A relatively high velocity stream of compressed gas (air), when blown across the opening of a tube set at 90 degrees to the air stream creates a low pressure at the opposite end of the perpendicular tube. This low pressure (vacuum) sucks up an abrasive powder from a reservoir and propels the abrasive thereby abrading the surface of an object in its path. The phenomenon is analogous to a perfume bottle. The abrasive powder behaves as the perfume, that is, as air is blown across the opening the abrasive powder is blown into the air stream.
Comparison of ACCU-PREP to the predicate device shows both are very similar with the major difference being esthetics. The proposed new products, Types I and II, are functionally identical to the predicate device but are more esthetically acceptable top the patient as well as to the dentistry and dental auxiliary. One notable difference between the tow is the applicant device operates at lower air pressure.
Both employ 50 um aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 um
Since both devices are appear essentially identical their performances were compared by testing in actual use situations. Shear bond tests were performed on human extracted teeth using identical conditions with the only difference being the device abrading the substrate. No statistically significant difference was found in this test at p ≥ 0.05. Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results.
James L. Sandvik
James L. Sandrik, Ph.D. BISCO. Inc. Itasca, IL 60143
February 7, 1997
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. James L. Sandrik, Ph.D. Director of Technical Affairs Bisco, Incorporated 1500 West Thorndale Avenue 60143 Itasca, Illinois
JUL ** 1 1997
K970484 Re : Accu-Prep Trade Name: Requlatory Class: III Product Code: KOJ February 7, 1997 Dated: February 10, 1997 Received:
Dear Dr. Sandrik:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker is substantially equivalent (for the indications for use stated in the enclosure) to 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). "You may, therefore, market the device, subject to the general controls provisions marrol one act. The general controls provisions of the Act -- include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not fication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Dr. Sandrik
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sio\n puivalence of your device to a legally Finalig of babbandabice results in a classification for your markets production of mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene orgulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
y A. Ulatowski Timo Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for ACCU-PREP™
INDICATIONS for USE
510(k) Number (if known): --
Device Name: ACCU-PREP
Indications for Use:.
-
- Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
-
- Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
-
- Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
- Porcelain etch substitute: for preparation of intaglio surface of porcelain 4. restorations in place of etching with hydrofluoric acid in the mouth.
-
- Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
-
- Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
-
- Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
-
- Endodontic post preparation : for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
- Denture repairs: for preparation of denture base to facilitate repairs. 9.
-
- Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before rebonding. For enhancement of adhesive to tooth structure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRL, Office of Device Evaluation (ODE)
(Division Sign-Off) Surar Rasver
Division of Dental, Infection Control,
and General Hospital Device
510(k) Number K170484
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)