(265 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
No.
The device is used for dental prophylaxis (polishing teeth) and does not treat or cure a disease or condition, which is a characteristic of therapeutic devices.
No
The device is described as a "dental low speed prophy air motor" that drives a prophy angle with polishing paste to polish teeth, clearly indicating it is used for a prophylactic treatment, not for diagnosis. There is no mention of diagnostic capabilities or measuring any physiological parameters.
No
The device description explicitly states it is a "dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface," indicating it is a physical hardware device, not software only. The performance studies also focus on hardware standards and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing dental prophylaxis by polishing teeth. This is a procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The description details a mechanical device (air motor) used to drive a polishing tool. It does not mention any components or processes related to testing samples or analyzing biological markers.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Diagnosis, monitoring, or screening of diseases based on sample analysis
- Use of reagents or assays
The tests mentioned (ISO standards for handpieces and motors, biocompatibility, cleaning, and sterilization) are relevant to medical devices used in direct patient care, but not specifically to in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.
Product codes
EFB
Device Description
Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.
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
Target Users: Professional dentists and hygienists
Location of Use: Dental offices
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
The following tests were conducted to evaluate the functional performance and safety of Premium Plus Prophy Air Motor:
- ISO 14457:2012 Dentistry Handpieces and Motors Test
- ISO 9168:2009 Dentistry Hose Connectors for Air Driven Dental Handpieces Test
The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements in ISO 14457:2012 and ISO 9168:2009, and is substantially equivalent for use as a dental prophy air motor.
Biocompatibility Test:
The following tests were performed to evaluate the biocompatibility of the device:
- Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- Oral Irritation per ISO 10993-10: Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity
- Sensitization per ISO 10993-10: Biological evaluation of medical device Part 10: Tests for irritation and delayed -type hypersensitivity
Validation Testings:
Recommendations of the FDA Guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed.
- Cleaning Validation Protein Analysis
- Cleaning Validation - Hemoglobin Analysis
- Sterilization Validation - Gravity cycle 132 ℃ 15min
- Sterilization Validation - Gravity cycle 121 ℃ 30min
- Sterilization Validation - Prevacuum cycle 132 ℃ 4min
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Premium Plus International Limited Jessica Mao QA Engineer Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West Yuen Long, N.T. Hong Kong, China
Re: K170261
Trade/Device Name: Premium Plus Prophy Air Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: September 11, 2017 Received: September 15, 2017
Dear Jessica Mao:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
October 19, 2017
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170261
Device Name Premium Plus Prophy Air Motor
Indications for Use (Describe)
The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Section 5 510(k) Summary
[As Required by 21 CFR 807.92]
Revision date: Oct. 17, 2017
Premium Plus International Limited Submitter: Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong, China (Establishment registration number: 3006847937)
Contact Person: Jessica Mao QA Engineer Tel: 852-27613211 Fax: 852-27613210 Email: jessicamao@premiumplushk.com
Trade/Device Name: Premium Plus Prophy Air Motor Common Name: Dental Handpiece Model Type: 1002-4 Device Panel: Dental Basis for Submission: New Device Regulation Name: Handpiece, Air-Powered, Dental Device Classification: Class I Regulation Number: 21 CFR 872.4200 Regulation Description: Dental Handpiece and Accessories Product Code: EFB
Predicate Device to Premium Plus Prophy Air Motor:
Trade Name: Prophy Star 3 Hygiene Handpiece 510(k) Number: K070869 Manufactured by: DentalEz Inc., StarDental Division
Device Description:
Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.
Indications for Use:
The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.
An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 1 of 4 Section 5
4
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG
Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Device | Prophy Star 3 Hygiene | ||
| Handpiece (K070869) | Premium Plus Prophy | ||
| Air Motor | / | ||
| Indications for | |||
| Use | The prophy handpiece is used | ||
| by trained dental | |||
| professionals to perform | |||
| dental prophylaxis | Premium Plus Prophy | ||
| Air Motor is intended to | |||
| be used with a | |||
| disposable prophy angle | |||
| and polishing paste by a | |||
| trained dental clinician | |||
| to perform dental | |||
| prophylaxis. | Same | ||
| Target Users | Professional dentists and | ||
| hygienists | Professional dentists | ||
| and hygienists | Same | ||
| Location of | |||
| Use | Dental offices | Dental offices | Same |
| Product | |||
| Design | Metal housing (external | ||
| casing) with internal drive | |||
| shaft, gearings and chuck | |||
| assembled and aligned to | |||
| each other. | Anodized aluminum | ||
| housing with internal | |||
| drive shaft, gearings | |||
| and chuck assembled | |||
| and aligned to each | |||
| other | Same | ||
| Dimensions & | |||
| Weight: | Length 108.99 mm | ||
| Diameter at handle 16.76 mm | |||
| Weight 62 grams | Length 111.00 mm | ||
| Diameter at handle 16.76 mm | |||
| Weight 69 grams | The | ||
| subject | |||
| device is a bit | |||
| longer, bigger, | |||
| and heavier than | |||
| the predicate | |||
| device. | |||
| Operating Air | |||
| Pressure, | |||
| Operating | |||
| Speed and | |||
| Power Output | Air Pressure 35-40 psi | ||
| Operating Speed 0 to 5,000 | |||
| rpm | |||
| Power Output 5.8 Watts | Air Pressure 200kPa | ||
| Operating Speed 0 to | |||
| 2,480 rpm | |||
| Power Output 6.0 Watts | Operating speed | ||
| is different | |||
| Drive | |||
| Mechanism | Chuck driven by pneumatic | ||
| air rotor | Chuck driven by | ||
| pneumatic air rotor | Same | ||
| Bio- | |||
| compatibility | Made of non-toxic anodized | ||
| aluminum | Biocompatibility tests | ||
| were conducted in | |||
| accordance with the | |||
| requirements of ISO | |||
| 10993-5 and ISO | Same | ||
| Compatibility | |||
| with other | |||
| dental devices | Designed to fit securely onto | ||
| standard Mid-West style air | |||
| hose connector and standard | |||
| Doriot style prophy angles | Designed to fit securely | ||
| onto standard 4-hole | |||
| (mid-west style) | |||
| connector and standard | |||
| Doriot style prophy | |||
| angles | Same | ||
| Sterility | Non-sterile | Non-sterile | Same |
| Mechanical | |||
| Safety | Robust construction to | ||
| withstand forces generated | |||
| during cleaning cycle | Robust construction to | ||
| withstand forces | |||
| generated during | |||
| cleaning cycle. The | |||
| subject device passed | |||
| the performance test in | |||
| accordance with ISO |
-
| Same |
Comparison of Technological Characteristics:
5
Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Discussion of similarities and differences between the Proposed Device and the Predicate Device
In compare to the Prophy Star 3 Hygiene Handpiece, the Premium Plus Prophy Air Motor has the same indications for use, same target users and same location of use. They both have the same drive mechanism. They both have similar dimensions & weight, similar operating air pressure and similar power output. Furthermore, they both are non-sterile, bio-compatible, compatible with the same type of air hose connector and same type of disposable prophy angle, and both are mechanically safe.
Their operational speeds are different. The subject device's operational speed is within the extent of the predicate device's speed. The subject device conforms to the requirements of ISO 14457.
Performance Test:
The following tests were conducted to evaluate the functional performance and safety of Premium Plus Prophy Air Motor:
- ISO 14457:2012 Dentistry Handpieces and Motors Test ●
- ISO 9168:2009 Dentistry Hose Connectors for Air Driven Dental Handpieces Test ●
The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements in ISO 14457:2012 and ISO 9168:2009, and is substantially equivalent for use as a dental prophy air motor.
An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 3 of 4 Section 5
6
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Biocompatibility Test:
The following tests were performed to evaluate the biocompatibility of the device:
- Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: ● Tests for in vitro cytotoxicity
- Oral Irritation per ISO 10993-10: Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity
- Sensitization per ISO 10993-10: Biological evaluation of medical device Part 10: Tests ● for irritation and delayed -type hypersensitivity
Validation Testings:
Recommendations of the FDA Guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed.
- Cleaning Validation Protein Analysis ●
- Cleaning Validation - Hemoglobin Analysis
- Sterilization Validation - Gravity cycle 132 ℃ 15min
- Sterilization Validation - Gravity cycle 121 ℃ 30min
- Sterilization Validation - Prevacuum cycle 132 ℃ 4min
Conclusion
Based on the above analysis, Premium Plus International Limited believes that the Premium Plus Prophy Air Motor is Substantially Equivalent to the claimed predicate, that is the Prophy Star 3 Hygiene Handpiece.