(6 days)
Not Found
No
The 510(k) summary describes a mechanical dental handpiece and does not mention any AI or ML components or functionalities.
No.
Explanation: The device is a dental handpiece used for general dentistry procedures like removing carious material, which is a restorative or surgical function, not therapeutic in the sense of treating a disease or condition to achieve a therapeutic effect.
No
The AHP-101 is described as a dental handpiece for general dentistry procedures like removing carious material, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "dental handpiece," which is a physical hardware device used in dentistry. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general dentistry procedures, such as removing carious material from the dentine." This describes a direct surgical/mechanical intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a dental handpiece that accepts burs and prophy angles, which are tools used for physical manipulation within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for general dentistry procedures, such as removing carious material from the dentine.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.
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)
Not Found
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.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
- 3 2005 MAY
Image /page/0/Picture/2 description: The image shows a logo for "ASEPTICO International". The logo is in a stylized font, with the word "ASEPTICO" in a larger font size than the word "International". The logo is in black and white, and the text is slightly distorted.
Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072
Telephone: (425) 487-3157 Fax: (360) 668-8722 Web: www.aseptico.com E-mail: grant(@aseptico.com
510(k) Summary
Contact: Grant Ramaley
Date Prepared: April 11, 2005
Trade or Proprietary Name: AHP-101 E-Type Straight Handpiece
Classification Name: 872.4200 Dental Handpiece and Accessories
510(k) Number:
Device Description:
The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.
Features of Substantial Equivalence to Aseptico's AHP-64 Handpiece [510(k) K020137]
- Intended for general dentistry procedures 1)
- Fits all E-type dental handpiece motors 2)
- Fully autoclavable. Independently validated sterility assurance level (SAL) of10° 3)
- Straight, 1:1 gear-ratio design 4)
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- 0 30,000 RPM input speed range
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- Constructed of stainless steel, brass, and anodized aluminum
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- Complies with applicable portions of the following standards: ISO 7785-2:1995, ISO 3964:1982, ISO 11134:1994, AAMI TIR No. 12-1994
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 the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.
Image /page/1/Picture/3 description: The image shows a date, "MAY - 3 2005". The month is MAY, the day is 3, and the year is 2005. The text is in a simple, sans-serif font and is easy to read.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aseptico, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K051077
Trade/Device Name: AHP-101 E-Type Straight Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: April 25, 2005 Received: April 27, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nated 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 approvisions 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 (1 Wri), It may of bagges in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of the read may publish further announcements concerning your device in the Federal Register
2
Page 2 - Mr. Lehtonen
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advised that 12 a determination that your device complies with other requirements mount that I Drima mires and regulations administered by other Federal agencies. or the rice of any - outh all the Act's requirements, including, but not limited to: registration 1 ou intist comply with a807); labeling (21 CFR Part 801); good manufacturing practice and fisting (2) 22 x 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betronic 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) This letter will and in you The FDA finding of substantial equivalence of your device to a premaired predicated. 22 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), rr you desire spocitiv at . 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,
Jenette G. Michie Oms.
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
3
Indications for Use
510(k) Number (if known): KSS1077
Device Name: AHP-101 E-Type Straight Handpiece
Indications for Use:
The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is THE Arlin "To Fraily datestal dentistry procedures, such as removing carious material from the dentine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSR
on of Anesthesiology, General Hospital, ection Control, Dental Devices
Number. K051017