(211 days)
Not Found
No
The summary describes a dental scaler and does not mention any AI/ML terms or functionalities.
Yes
The device is intended to remove calculus or stains and clean the root canal, which are therapeutic procedures to treat dental conditions.
No
Explanation: The device is intended for removing calculus or stains and cleaning root canals, which are therapeutic or prophylactic procedures, not diagnostic ones.
No
The description clearly indicates the device is used for physical procedures (removing calculus/stains, cleaning root canals) and references a predicate device (SATELEC SUPRASSON P5 BOOSTER) which is a physical ultrasonic scaler, strongly suggesting this is a hardware device.
Based on the provided information, the Apoza Selector U2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to remove calculus or stains from teeth and clean root canals. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Anatomical Site: The device is used on the surface of teeth and in the root canal, which are parts of the patient's anatomy.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), using reagents, or providing diagnostic information about a disease or condition.
Therefore, the Apoza Selector U2 is a dental device used for therapeutic and prophylactic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth or clean the root canal ( with endo-kit) in the prophylaxis procedures.
Product codes
ELC
Device Description
The Apoza Selector U2 is designed for the deatists to remove the calculus or stains on surface of teeth or clean the root canal ( with endo-kit) in the prophylaxis procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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
performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use.
Key Metrics
Not Found
Predicate Device(s)
SATELEC SUPRASSON P5 BOOSTER K961158
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
5. 510(K) SUMMARY
APR 3 0 2004
APOZA ULTRASONIC SCALER AND ENDODONTIC'S UNIT Models: SELECTOR U2
510K:
| Submitted by: | APOZA ENTERPRISE CO, LTD. |
|---|---|
| 6F, No.657, Chuang Chong Road, Hsin-Chuang City, | |
| Taipei Hsien, China (Taiwan) | |
| Contact person: | General Manager |
| Mr. SHIH MIN-TEH |
September 27, 2003 Date Summary Prepared:
Classification name: Scaler, Ultrasonic ●
ELC', Class H ● Classification number:
Regulation Number: 872.4850
.
.
.
SCALER AND ULTRASONIC Proprietary name: APOZA ENDODONTICS UNIT, SELECTOR 02
Common name of device: Ultrasonic Scaler .
SATELEC SUPRASSON P5 BOOSTER Predicate Device:
510K No K961158
Tre Apoza Selector U2 is designed for the deatists to Statement of Intended Use: remove the calculus or stains on surface of teeth or clean the root canal ( with endo-kit) in the prophylaxis procedures. - The device carries the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
1
Comparison to Predicate Devices: The APOZA Ultrasonic Scaler, Sciector U2, has
been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addinon, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use. We believe that the APOZA Ultrasonic Scaler, Selector U2 is substantially equivalent to the predicate device, i.e., SATELEC SUPRASSON P5 BOOSTER(K961158), and the data provided support the safety and effectiveness of Selector 'J2 for the intended uses.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes across its body, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Mr. Shih Min-Teh Official Correspondent Apoza Enterprise Company, Limited 6 F, No. 657, Chuang-Cheng Road, Hsin-Chuang City, Taipei Hsicn, CHINA (Taiwan) 242
Re: K033198
Trade/Devicc Name: Apoza Ultrasonic Scaler and Endodontics Unit, Selector U2 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 9, 2004 Received: February 17, 2004
Dear Mr. Min-Tch:
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.
3
Page 2 - Mr. Min-Teh
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
ClsLs
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
4
INDICATIONS FOR USE STATEMENT 4.
Applicant : ___________________________________________________ 510(k) Number : TO BE ASSIGNED APOZA ULTRASONIC SCALER AND Device Name . . ENDODONTICS UNIT, SELECTOR U2
Indications for Use :
The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth er clean the root canal ( with endo-kit) in the prophylaxis procedures.
The device carries the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
ULTEAN! DO MOLEVRITOW THIS LINE-CONTINUE ON ANSITUAR LAGE IN NEFARTO Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801 109
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Over-The-Counter
(Optional Formal 1-2-96)
Robert S. Betz for Dr. Susan Renner
510(k) Number: K033198