(77 days)
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No
The summary describes a mechanical sandblasting device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a "clinical sandblaster" used for surface preparation of dental materials (e.g., crowns, bridges, posts) and removal of cement, which are restorative and preparatory procedures, not therapeutic ones directly treating a disease or condition.
No
The device description focuses on its function as a sandblaster for surface preparation (e.g., prior to cementation, removing residual cement, enhancing bonding), not on detecting, diagnosing, or monitoring medical conditions.
No
The device is described as a "clinical sandblaster," which is a physical piece of equipment used in dentistry. The intended uses clearly describe physical actions performed by a sandblaster on dental materials. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described for the Ultra-Blaster are all related to the preparation and manipulation of dental materials and surfaces outside of the human body, specifically for procedures like cementation, bonding, and cleaning of dental prosthetics and structures.
- IVD Definition: In Vitro Diagnostics are defined as tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
The Ultra-Blaster's function is purely mechanical and preparatory for dental procedures, not for analyzing biological samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
Ultra-Blaster 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 bridges. .
- Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluric 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 endodontic posts prior to cementation. .
- 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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1998
Mr. Chester McCoy ·Requlatory Affairs Manager Ultradent Products Incorporated 505 West 10200 South South Jordan, Utah 84095
Re : K980726 Ultra-Blaster Trade Name: Requlatory Class: III Product Code: KOJ Dated: February 20, 1998 February 24, 1998 Received:
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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, Druq, and Cosmetic Act (Act). 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 (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 notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. McCoy
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Ultra-Blaster 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 bridges. .
-
Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluric 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 endodontic posts prior to cementation. .
-
Sandblasting of all surfaces to be bonded. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Runres
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K98076 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
- May
(Optional Format 1-2-96)