(94 days)
K#033812
Not Found
No
The summary describes a mechanical air-powered scaler and does not mention any AI or ML components or functionalities.
Yes
The device is used for dental cleaning and periodontal therapy, which are therapeutic interventions aimed at maintaining or restoring oral health by removing calculus deposits from teeth.
No
The device is described as an air-powered scaler used for removing calculus deposits from teeth during dental cleaning and periodontal therapy, which is a treatment function, not a diagnostic one.
No
The device description explicitly mentions hardware components like a handpiece, scaler tip, tubes, and connections to a dental unit, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove calculus deposits from teeth during dental cleaning and periodontal therapy. This is a therapeutic and mechanical action performed directly on the patient's teeth.
- Device Description: The description details a dental handpiece scaler that uses air and water to vibrate a tip for calculus removal. This is a physical process.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Air Solfy performs a physical procedure on the teeth, not an analysis of a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Air Solfy can be used to remove calculus deposits from teeth by application of an air-powered vibrating scaler tip from the teeth during dental cleaning and periodontal therapy.
The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
This device receives energy resorces in handpiece such as air for high speed air turbine, cooling water for scaling and light source for illumination, through the tubes connected to a dental unit.
The cooling water is fed on the part of scaling treatment through pouring holes.
Air Solfy is classified into the model as is shown below Table-1 from the variations of connection, light or power adjuster.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental cleaning and periodontal therapy
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.
K#033812
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
510(k) SUMMARY
J. MORITA MFG. CORP.'s Air Solfy
Name of Device and Name/Address of Sponsor
| Trade or Proprietary Name: | Air Solfy AS series
(AS-4H/ AS-4H-O/ AS-4H-V/ AS-4H-OV and
AS-1/ AS-1-O/ AS-1-V/ AS-1-OV) |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Dental scaler |
| Classification Name: | Dental Handpiece and accessories (21CFR872.4200) |
| Product Code : | EFB ("Handpiece, Air-powered, Dental) |
| Registration No. 2081055 | Registration No. 3002807636 |
| Initial Distributor: | Manufacturer: |
|---|---|
| J. Morita USA, Inc. | J. MORITA MFG. CORP. |
| 9 Mason | 680 Higashihama Minami-cho |
| Irvine, CA 92618 | Fushimi-ku, Kyoto |
| USA | Japan 612-8533 |
| Telephone: | 949-581-9600 |
| +81-75-611-2141 | |
| Facsimile: | 949-581-9688 |
| +81-75-605-2354 |
Intended Use
.
The Air Solfy can be used to remove calculus deposits from teeth by application of an air-powered vibrating scaler tip from the teeth during dental cleaning and periodontal therapy.
Technological Characteristics and Substantial Equivalence
This device receives energy resorces in handpiece such as air for high speed air turbine, cooling water for scaling and light source for illumination, through the tubes connected to a dental unit.
The cooling water is fed on the part of scaling treatment through pouring holes.
Air Solfy is classified into the model as is shown below Table-1 from the variations of connection, light or power adjuster.
1
| ml:
1
1 | €
1
1 | |
|---------------|-------------|--|
| | | |
| Table-1 | Model of Air Solfy |
|---|---|
| --------- | -------------------- |
| ( - : not included ) | ||||
|---|---|---|---|---|
| Model | Connection | Light | Power | |
| Adjuster | Autoclave | |||
| AS-1 | They can be | - | - | |
| AS-1-O | connected to the | Included | - | Autoclavable |
| AS-1 V | MORITA original | - | Included | |
| AS-1-O V | a joint. | Included | Included | |
| AS-4H | They can be | - | - | |
| AS-4H-O | connected to the | Included | - | Autoclavable |
| AS-4H V | CP4 or CP4-O | - | Included | |
| AS-4H-O V | coupling. NOTE-1 | Included | Included |
NOTE-1 CP4 or CP4-O is the ISO9168 type C coupling.
Air Solfy covered by this submission is substantially equivalent to other legally marketed device. Specifically, Air Solfy is substantially equivalent to the Siroair L air marketed do from Sirona dental syatem , Inc(K#033812). Air Solfy has similar general seater "from Birona contraciples of operation, and similar technological characteristics as the previously cleared predicate device, Siroair L air scaler.
Although we cannot compare specifications of them minutely as we have not obtained Andrough Tre Sailfor sons of Siroair L, but we are able to figure out the specifications und equivalence as there exists a common international standard on the dental airand equivaliere of ISO 15606. Air Solfy is in compliance with ISO 15606:1999.
The Air Solfy's substantial equivalence to Siroair L is demonstrated at Comparison Summary Table as below.
Although there are minor differences in the characteristics of Air Solfy and its predicate device, these differences do not raise new questions of safety or effectiveness.
2
| FDA file reference number | 510k number
K033812 |
|-----------------------------------------------------|------------------------|
| Attachment inside notification submission file | 510k FDA |
| TECHNOLOGICAL
CHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment
and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
Substantial Equivalent comparison table
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, representing medicine and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2005
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11th Floor Washington, DC 20005
Re: K043497
Ro43477
Trade/Device Name: Air Solfy Air Powered Dental Handpiece Scaler and Tips Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: March 3, 2005 Received: March 4, 2005
Dear Mr. Barritt:
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 included a or 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 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 Eederal Register.
4
Page 2 - Mr. Barritt
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basean and many of the with other requirements mean that I DA has made a determinations administered by other Federal agencies. of the Act of ally I edelar statues and registered.
You must comply with all the Act s requirements, including, but not limited to: registration 1 out must comply with an any labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Patt 607), labeling (21 CFR Part 820); and if requirents as set forth in the quality byocans (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) I mis letter will anow you to begin maliering of substantial equivalence of your device to a premiarket notification. THE I D. I mails 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), IT you desire specific advice for Jour at (240) 276-0115. Also, please note the regulation in prease contact the Other or Somphise or premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miernational and Consumer Assistance at its toll-free Driston 01 01 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
Chiu Lin, Ph.D.
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
5
Indications for Use
510(k) Number (if known): K043497
AIR SOLFY AIR POWERED DENTAL HANDPIECE SCALER AND TIPS Device Name: Indications For Use:
The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruane
11 0. 201
; (2010) Par
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