(13 days)
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No
The document describes a standard ultrasonic scaler with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
Explanation: The device is intended for therapeutic procedures such as scaling and endodontics, which involve treating dental conditions and pathologies.
No.
The device is an ultrasonic scaler intended for dental procedures like scaling and endodontics (Pulp Chamber Cleaning, Canal filling), which are therapeutic or treatment procedures, not diagnostic ones.
No
The device description explicitly states it is an "AC mains-powered piezoelectric ultrasonic scaler" and lists hardware components like a console, footswitch, and handpiece. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ASC-12 Function: The ASC-12 is an ultrasonic scaler used for dental procedures performed directly on the patient's teeth and within the mouth. It physically removes calculus and performs endodontic procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes procedures performed in vivo (within the living body), not in vitro (in glass or outside the body).
Therefore, based on the provided information, the ASC-12 is a medical device used for dental treatment, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment
Tooth neck and subgingival treatment
Treatment of large dental calculi
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning
Canal filling by ultrasonic gutta-percha condensation
Product codes
ELC
Device Description
The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler The device consists of a console, a intended for scaling and endodontic procedures. footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
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
The following intended were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
K0708166
Telephone: (425) 487-3157
Image /page/0/Picture/1 description: The image shows a logo for "ASEPTICO International". The logo features stylized, bold lettering for the word "ASEPTICO", with the word "International" written in a smaller, elegant font underneath. To the right of the text is a graphic that resembles a globe, adding a global or international dimension to the brand's identity.
Fax: (360) 668-8722 Web: www.aseptico.com E-mail: mwaller@aseptico.com Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072
APR 1 1 2007
510(k) Summary
Grant Ramaley, Director of Regulatory Affairs Contact:
Date Prepared: January 10, 2007
Trade or Proprietary Name: Model ASC-12 Piezoelectric Scaler
Classification Name: 8872.4850 Ultrasonic scaler
510(k) Number:
Device Description: The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler The device consists of a console, a intended for scaling and endodontic procedures. footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
The following intended were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data.
Features of Substantial Eguivalence to the Satelec Suprasson P5 Booster - 510(k) #K961158 and the NSK Varios 350 - 510(k) #K031421
| 1) Intended Use: scaling and endodontic procedures, including: | |
|---|---|
| Scaling: | Interdentium treatment |
| Tooth neck and subgingival treatment | |
| Treatment of large dental calculi | |
| Treatment of coatings and tobacco stains | |
| Treatment of periodontal pockets | |
| Interproximal treatment | |
| Loosening of crowns and posts | |
| Endodontics: | Pulp Chamber Cleaning |
| Canal filling by ultrasonic gutta-percha condensation |
-
- Design & Construction: AC mains-powered piezoelectric ultrasonic scaler consisting of a console, a footswitch and a handpiece with interchangeable scaling tips. Coolant may be supplied by connection to an external water source.
- Sterility Assurance: Handpiece and scaling tips are removable and autoclavable 3)
-
- Performance:
- a. The vibration frequency is between 27 and 32 kHz
- b. Scaler coolant flow is between 12 ml and 82 ml at the tip
- c. Water pressure rating is between 14.5 to 73 pso (1 to 5 bar)
-
- Electrical Safety Specifications: Class II equipment with Type BF applied part
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA", indicating the department's name and national affiliation.
APR 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aseptico, Incorporated C/O Ms. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K070866
Trade/Device Name: ASC-12 Piezoelectric Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 26, 2007 Received: March 29, 2007
Dear Ms. Conry:
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.
2
Page 2 - Ms. Conry
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Smythe Y. Michie Davis.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K070866 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ASC-12 Piezoelectric Scaler
Indications for Use:
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment Tooth neck and subgingival treatment Treatment of large dental calculi Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning Canal filling by ultrasonic gutta-percha condensation
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Susan Concurrence of CDRH, Office of Device Evaluation (ODE)
entologic Corporal Hospital 11 11:21: ion Gentrol, Dental Devioes
. (k) Number..