ULTRA-BLASTER

K980726 · Ultradent Products, Inc. · KOJ · May 12, 1998 · Dental

Device Facts

• Record ID: K980726
• Device Name: ULTRA-BLASTER
• Applicant: Ultradent Products, Inc.
• Product Code: KOJ · Dental
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2

Intended 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. .

Device Story

Ultra-Blaster is an autoclavable clinical sandblaster used by dental professionals. Device functions as a mechanical surface preparation tool; utilizes abrasive particles to abrade surfaces of dental restorations (crowns, inlays, bridges, endodontic posts) and orthodontic bands. Operation involves sandblasting surfaces to enhance bonding, remove residual cement, or restore acrylic facings; serves as an alternative to hydrofluoric acid for porcelain/resin repairs. Output is a physically abraded surface optimized for subsequent clinical procedures. Used in dental clinics to improve retention and bonding efficacy of dental materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Autoclavable clinical sandblaster; mechanical abrasive surface preparation device. No electronic components, software, or energy source specified beyond pneumatic/mechanical operation.

Indications for Use

Indicated for dental clinical use to prepare surfaces (metal, porcelain, resin, orthodontic bands, endodontic posts) for bonding, cementation, or repair, and to remove residual cement from dental restorations.

Regulatory Classification

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.

Special Controls

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.”

Submission Summary (Full Text)

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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. .

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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 | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use |
|----------------------|-----------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

- May

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