(38 days)
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K0J
No
The provided text describes a mechanical sandblaster and does not mention any AI or ML components or functionalities.
No
The device is described as a clinical sandblaster used for surface preparation of dental materials (e.g., metal, porcelain, resin) and removal of cement, which are preparatory steps for dental procedures rather than direct treatment or diagnosis of a condition.
No
The device is described as a clinical sandblaster used for surface preparation (e.g., sandblasting metal, porcelain, resin surfaces prior to cementation or bonding, removing residual cement) and restoration, not for diagnosing medical conditions.
No
The device description explicitly states "Miniblaster is an autoclavable clinical sandblaster," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended uses of the Miniblaster all involve working directly on dental materials and surfaces (metal, porcelain, resin, acrylic) within the oral cavity or on dental prosthetics.
- The description focuses on a mechanical process (sandblasting) for surface preparation and cleaning. This is a physical manipulation of materials, not a diagnostic test performed on biological samples.
The Miniblaster is a dental device used for preparing and cleaning dental materials and surfaces.
N/A
Intended Use / Indications for Use
Miniblaster is an autoclavable clinical sandblaster for:
- Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
- Sandblasting to remove residual cement from crowns and bridged. .
- Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs.
- Sandblasting of orthodontic bands removes cement and enhances bonding. ●
- Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ●
- Sandblasting of all surfaces to be bonded. .
Product codes
KOJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Dr. Alan Edel Deldent Limited 19 Keren Kayement Street Petach Tikvah, ISRAEL
Re: K013969
Trade/Device Name: MiniBlaster Clinical Sandblaster Regulation Number: 872.6080 Regulation Name: Microabrasion Sandblaster Regulatory Class: II Product Code: KOJ Dated: November 27, 2001 Received: December 3, 2001
Dear Dr. Edel:
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 Federal Register.
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.
1
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); 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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timot Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name: | Miniblaster Clinical Sandblaster |
| Indications for Use: |
Miniblaster is an autoclavable clinical sandblaster for:
- Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
- Sandblasting to remove residual cement from crowns and bridged. .
- Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs.
- Sandblasting of orthodontic bands removes cement and enhances bonding. ●
- Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ●
- Sandblasting of all surfaces to be bonded. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Penner
'Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devides F 1 Q(k) Number _