(348 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML. The "adjustable spray feature" is a manual setting, not an intelligent system.
Yes
The device is intended for prophylaxis treatments, including cleaning and polishing teeth, removing deposits, and non-surgical removal of subgingival plaque, which are therapeutic medical interventions.
No
The device is described as an air polishing device/powder jet handpiece intended for prophylaxis treatments, including cleaning and polishing teeth and removing subgingival plaque. Its function is to perform a physical treatment (cleaning/polishing/removing plaque) rather than to diagnose a condition or disease.
No
The device description clearly outlines a physical handpiece with various accessories (cannulas, wrench, gripping sleeves, powder container, etc.) that projects a mixture of water, air, and powder. This is a hardware device, not software only.
Based on the provided information, the PROPHYflex 4 Handpiece and Accessories is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PROPHYflex 4 Function: The PROPHYflex 4 is a dental handpiece that performs prophylaxis treatments by projecting a mixture of water, air, and powder onto the teeth and into subgingival pockets. It is a therapeutic and cleaning device used directly on the patient's body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens to provide diagnostic information. Its function is purely mechanical/physical cleaning and polishing.
Therefore, the PROPHYflex 4 Handpiece and Accessories falls under the category of a medical device used for treatment and cleaning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PROPHYflex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subgingival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Product codes
EFB
Device Description
The PROPHYflex 4 is an air polishing device/powder jet handpiece that projects a mixture of water and air with sodium bicarbonate, calcium carbonate or fine glycine power onto tooth surfaces. The device includes the handpiece main body with adjustable spray feature, two cannulas, a wrench for installing the cannula, two interchangeable gripping sleeves, powder container with cover, a cleaning burr and nozzle pin, and a set of spare o-rings. An optional adapter and perio tip can be installed for subgingival treatments.
The powder is filled into the powder container by the user. When activated through foot control, air is pushed into the powder container, swirling the powder and pushing it through the device and out of the cannula. The spray is only mixed with the air and powder at the very tip of the cannula, providing an even and gentle cleaning effect. The amount of powder can be regulated via three different spray settings by the adjusting ring, helping the users to perform individual treatments such as subgingival biofilm removal, removal of discoloration and bacterial plaque, orthodontics, cleaning prior to fissure sealing, prosthetics, conservative and aesthetic dentistry by providing the possibility to adjust the cleaning effects to the clinical situation of the patient at hand.
The components of the PROPHYflex 4, including the powder container, is to be completely reprocessed after each use.
The three powder levels are as follows:
- Highest Level: Suitable for supragingival treatment and offers full cleaning power.
- Medium Level: Suitable for sub- and supragingival treatment and enables gentle cleaning at a reduced powder quantity.
- Lowest Level: Helps rinsing the powder off the tooth and blowing the powder from the system after the treatment.
During supraqinqival treatments (e.g. stain removal), the device doesn't touch the patient but will be placed 3 – 5 mm from the area that is to be cleaned. During subgingival treatments (biofilm management) with the perio tip, the tip is inserted into the pocket up to 5mm and angled towards the tooth.
Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Kaltenbach and Voigt GmbH is bundling the PROPHYflex 4 Dental Handpiece and Accessories models listed below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models are coupler adapter and color selection. All critical components within the PROPHYflex 4 Dental Handpiece and Accessories are common.
The PROPHYflex 4 Dental Handpiece and Accessories are available in the following models in table 5.1 below.
| Series | Model | Description |
|---|---|---|
| PROPHYflex 4 | 3.002.8000 | PROPHYflex 4 - Wave color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.002.8200 | PROPHYflex 4 - Lime color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.002.8800 | PROPHYflex 4 - Flamingo color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.004.5900 | PROPHYflex 4 S - Wave color PROPHYflex 4 for use with Sirona coupler |
| PROPHYflex 4 | 3.004.5930 | PROPHYflex 4 S - Lime color PROPHYflex 4 for use with Sirona coupler |
| PROPHYflex 4 | 3.004.5950 | PROPHYflex 4 S - Flamingo color PROPHYflex 4 for use with Sirona coupler |
Accessories:
Optional accessories (devices) that are integrated/attached to the PROPHYflex 4 Handpiece and Accessories are 510(k) Exempt devices and have been tested as part of the PROPHYflex 4 Handpiece and Accessories Performance Bench Testing (Section 18). Also, Kaltenbach and Voigt GmbH has quality system processes implemented for risk assessment for devices manufactured in compliance with ISO 14971:2007 as referenced in section 9 (Declarations of Conformity and Summary Reports). This includes the PROPHYflex 4 Handpiece and Accessories with attached/integrated Devices / Accessories listed below in Table 5.2.
| Device /
| Accessory | Device Description | Manufacturer | Product Code | 510(k) Clearance |
|---|---|---|---|---|
| PROPHYflex | ||||
| Powder - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Berry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Cherry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Mint | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Neutral | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Mint | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Peach | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Black Currant | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Perio Powder | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces, pockets up to 5 mm (subgingival)
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)
Performance bench testing according to international standards for dental handpieces has been conducted to determine conformance in regards to:
- Biocompatibility has been completed for the applicable components.
- Comparative performance testing of the functions of the integrated accessories as compared to the cleared stand-a-lone device.
Furthermore, the performance of the PROPHYflex 4 Handpiece and Accessories has been verified utilizing the following standards:
- ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Including: Amendment 1 (2013)).
- ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces.
- ISO 17665-1 First edition 2006-08-15 - Sterilization of health care products - Moist heat - part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- AAMI / ANSI ST79 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- ISO 20608:2017 - Air driven powder jet handpieces and powders
- AAMI / ANSI / ISO 10993-1:2009/(R)2013 - Biological evaluation of medical devices part 1: evaluation and testing within a risk management process.
- ISO 10993-5 Third edition 2009-06-01 - Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity.
- ISO 10993-10:2010 (3rd ed) 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-18 First edition 2005-07-01 Chemical characterization of materials
- ISO 14971 Second Edition 2007-03-01, Medical Devices Application of risk management to medical devices.
- Guidance for Industry and FDA Staff:2007-05-02 - Dental Handpieces - Premarket Notification [510(k)] Submissions
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AIR-FLOW Handy 3.0 Plus (K151912)
Reference Device(s)
AIR-FLOW handy 3.0 PERIO (K132480), PROPHYflex 2 (K973876), SMARTmatic (K163239), ELECTROmatic (K163317)
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
Indications for Use
510(k) Number (if known) K181110
Device Name PROPHYflex 4
Indications for Use (Describe)
The PROPHY flex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subgingival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
| 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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1
Image /page/1/Picture/0 description: The image shows the logo for KaVo Dental Excellence. The logo consists of the word "KAVO" in a bold, sans-serif font, with the "A" stylized to resemble a dental tool. Below the word "KAVO" is the phrase "Dental Excellence" in a smaller, sans-serif font.
Section V - 510(k) Summary for PROPHYflex 4
Handpiece and Accessories
-
- Submitter Information:
Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Germany
- Submitter Information:
| Contact Person: | Frank Ray |
|---|---|
| Telephone Number: | (704) 587-7227 |
| Fax Number: | (704) 587-7250 |
Date Prepared: April 10, 2019
2. Device Name:
.
- Proprietary Name: PROPHYflex 4
- Manufacturer: .
Kaltenbach & Voigt GmbH
- Dental Handpiece
- Classification Name: Dental Handpiece and Accessories ●
- CFR Number: .
Common Name:
-
. Device Class:
872.4200 I -
Product Code: EFB .
3. Predicate Device:
●
.
- AIR-FLOW Handy 3.0 Plus (K151912) Proprietary Name: ●
- Manufacturer: E.M.S. Electro Medical Systems S.A.
- Common Name: Dental Handpiece
- Classification Name: Dental Handpiece and Accessories ●
- 872.4200 I
- Device Class: ●
CFR Number:
O
O
- . Product Code: EFB
Reference Predicate #1:
- Proprietary Name: AIR-FLOW handy 3.0 PERIO (K132480)
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Manufacturer:
- Dental Handpiece o Common Name:
- Classification Name: Dental Handpiece and Accessories O
I
- 872.4200 o CFR Number:
- O Device Class:
- Product Code: EFB o
2
Reference Device #2:
O
o
- Proprietary Name: PROPHYflex 2 (K973876) o
- Manufacturer: Kaltenbach & Voigt GmbH
I
- Common Name: Dental Handpiece o
- Classification Name: Dental Handpiece and Accessories
- CFR Number: 872.4200 O
- Device Class: O
- Product Code: EFB o
Reference Device #3:
- Proprietary Name: o SMARTmatic (K163239) Kaltenbach & Voigt GmbH
- Manufacturer: o
- Common Name: Handpiece, belt and/or gear driven, dental o
- Classification Name: Dental Handpiece and Accessories o
- 872.4200 o CFR Number:
- Device Class: I O
- Product Code: EFA o
Reference Device #4:
- Proprietary Name: ELECTROmatic (K163317) o Kaltenbach & Voigt GmbH Manufacturer: O Common Name: Dental Handpiece O Classification Name: Dental Handpiece and Accessories O CFR Number: 872.4200 O Device Class: I o Product Code: EBW o
4. Description of Device:
The PROPHYflex 4 is an air polishing device/powder jet handpiece that projects a mixture of water and air with sodium bicarbonate, calcium carbonate or fine glycine power onto tooth surfaces. The device includes the handpiece main body with adjustable spray feature, two cannulas, a wrench for installing the cannula, two interchangeable gripping sleeves, powder container with cover, a cleaning burr and nozzle pin, and a set of spare o-rings. An optional adapter and perio tip can be installed for subgingival treatments.
The powder is filled into the powder container by the user. When activated through foot control, air is pushed into the powder container, swirling the powder and pushing it through the device and out of the cannula. The spray is only mixed with the air and powder at the very tip of the cannula, providing an even and gentle cleaning effect. The amount of powder can be regulated via three different spray settings by the adjusting ring, helping the users to perform individual treatments such as subgingival biofilm removal, removal of discoloration and bacterial plaque, orthodontics, cleaning prior to fissure sealing, prosthetics, conservative and aesthetic dentistry by providing the possibility to adjust the cleaning effects to the clinical situation of the patient at hand.
3
The components of the PROPHYflex 4, including the powder container, is to be completely reprocessed after each use.
The three powder levels are as follows:
- Highest Level: Suitable for supragingival treatment and offers full cleaning power .
- Medium Level: Suitable for sub- and supragingival treatment and enables . gentle cleaning at a reduced powder quantity
- . Lowest Level: Helps rinsing the powder off the tooth and blowing the powder from the system after the treatment
During supraqinqival treatments (e.g. stain removal), the device doesn't touch the patient but will be placed 3 – 5 mm from the area that is to be cleaned. During subgingival treatments (biofilm management) with the perio tip, the tip is inserted into the pocket up to 5mm and angled towards the tooth.
Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Kaltenbach and Voigt GmbH is bundling the PROPHYflex 4 Dental Handpiece and Accessories models listed below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models are coupler adapter and color selection. All critical components within the PROPHYflex 4 Dental Handpiece and Accessories are common.
The PROPHYflex 4 Dental Handpiece and Accessories are available in the following models in table 5.1 below.
| Series | Model | Description |
|---|---|---|
| PROPHYflex 4 | 3.002.8000 | PROPHYflex 4 - Wave color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.002.8200 | PROPHYflex 4 - Lime color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.002.8800 | PROPHYflex 4 - Flamingo color PROPHYflex 4 for use with KaVo MULTIflex coupler |
| PROPHYflex 4 | 3.004.5900 | PROPHYflex 4 S - Wave color PROPHYflex 4 for use with Sirona coupler |
| PROPHYflex 4 | 3.004.5930 | PROPHYflex 4 S - Lime color PROPHYflex 4 for use with Sirona coupler |
| PROPHYflex 4 | 3.004.5950 | PROPHYflex 4 S - Flamingo color PROPHYflex 4 for use with Sirona coupler |
Table 5.1
Accessories:
Optional accessories (devices) that are integrated/attached to the PROPHYflex 4 Handpiece and Accessories are 510(k) Exempt devices and have been tested as part of the PROPHYflex 4 Handpiece and Accessories Performance Bench Testing (Section 18). Also, Kaltenbach and Voigt GmbH has quality system processes implemented for risk assessment for devices manufactured in compliance with ISO 14971:2007 as referenced in section 9 (Declarations of Conformity and Summary Reports). This includes the PROPHYflex 4 Handpiece and Accessories with attached/integrated Devices / Accessories listed below in Table 5.2.
4
| Table 5.2 | ||||
|---|---|---|---|---|
| Device / | ||||
| Accessory | Device Description | Manufacturer | Product Code | 510(k) Clearance |
| PROPHYflex | ||||
| Powder - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Berry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Cherry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Powder - Mint | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Neutral | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Mint | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Peach | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYpearls - Black Currant | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex | ||||
| Perio Powder | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
Principle of Operation / Mechanism of Action:
PROPHYflex 4 connects to a dental treatment unit's tubing via KaVo MULTIflex coupler or a Sirona coupler that supplies air and water to the handpiece separately. The air is redirected through the PROPHYflex 4 main body to the powder container. The powder container – holding the sodium bicarbonate or calcium carbonate or glycine powder – is filled according to the treatment indication. The air draws the powder from the container to the cannula in the front of the handpiece. There, the powder is mixed with water that has been transported from the dental treatment unit coupling system to the tip of the cannula focuses this air, water and powder mixture into a stream. The air and water can be adjusted at the dental treatment unit or via the treatment unit foot control. The powder can be adjusted to 3 different levels using the adjustable ring at the base of the PROPHYflex 4 handpiece.
5. Indications for Use:
The PROPHYflex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subginqival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
5
6. Description of Substantial Equivalence: Technological Characteristics:
The proposed device (PROPHYflex 4 Handpiece and Accessories) from Kaltenbach & Voigt GmbH function in a manner similar to and are intended for the same indications for use as the predicate device AIR-FLOW Handy 3.0 Plus (K151912) marketed by E.M.S. Electro Medical Systems S.A.. There are numerous similar design, materials, and technological characteristics such as indications for use, Subgingival usage depth to 5mm, principle of operation, air polishing, max mode operation, internal spray, air/water ports, coupling dimensions, transportation and connections (Air pressure and relative humidity), as the ability to connect to KaVo MULTI-flex coupling and Sirona coupling.
In addition, both the proposed device (PROPHYflex 4 Handpiece and Accessories) and the predicate device AIR-FLOW Handy 3.0 Plus (K151912) provide air for dental handpieces by using a connection according to ISO 7785-1, ISO 14457 and ISO 9168 (2009-07-15 - Dentistry - Hose connectors for air driven dental handpieces). Furthermore, both the proposed device and the predicate device complies with conformance standard DIN 19402 (Powder Jet Handpieces) and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system).
However, there are different technological characteristics such as the proposed device has a Middle Mode and a Spray-function Mode (without powder, water only) capability where the predicate device does not. The proposed device is 10 mm shorter and 3 mm thinner than the predicate device and as well as being 5.9 dB guitter than the predicate device. The proposed device operating temperature is 18.0°C – 25.1°C where the predicate is 19.93°C – 23.33°C. The Maximum Air Pressure for the proposed device is 3.2 - 5 bar (46 - 73 psi) where the predicate is 2.7 – 3.5 bar (39 – 51 psi). The Air and water supply for the proposed device is 6.4 – 14.3 NI/min and the predicate is 10.3 – 13.5 NI/min. The proposed device Maximum water pressure is 1.0 - 2.5 bar (15 - 36 psi) where the predicate is 1.0 - 2.2 bar (15 - 32 psi). The spray water for the proposed device is 28 – 54 ml/min where the predicate is 106 ml/min.
These different technological characteristics do not raise new concerns of substantial equivalence. The comparison table below (table 5.3) for the PROPHYflex 4 Handpiece and Accessories (proposed device) and the AIR-FLOW Handy 3.0 Plus (K151912) (predicate device) are substantially equivalent in terms of indication for use, technology and performance specifications as the few differences between the proposed device and the predicate device do not impact substantial equivalence. The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use. Hence, the device is deemed to be substantially equivalent to the AIR-FLOW Handy 3.0 Plus (K151912).
Please note, reference device #2 (PROPHYflex 2 and Accessories (K973876)) is references as it has numerous identical features as the Proposed Device (PROPHYflex 4). Reference Device #1 is listed to support the indications for use. Reference devices 3 and 4 (SMARTmatic - K163239 and ELECTROmatic - K163317) are referenced in Biocompatibility section as they contain numerous identical patient contacting materials.
6
Device Comparison Table:
Table 5.3
| Table 5.3 | ||||
|---|---|---|---|---|
| Descriptive | ||||
| Information | Proposed Device | |||
| PROPHYflex 4 and | ||||
| Accessories | Predicate Device | |||
| AIR-FLOW Handy | ||||
| 3.0 Plus (K151912) | Reference Device #2 | |||
| PROPHYflex 2 and | ||||
| Accessories | ||||
| (K973876) | Reference | |||
| Predicate #1 | ||||
| AIR-FLOW handy | ||||
| 3.0 PERIO | ||||
| (K132480) | ||||
| Indications for Use | ||||
| Indications for | ||||
| Use | The PROPHYflex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subgingival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. | The AIR-FLOW handy 3.0 PLUS is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. |
The AIR-FLOW handy 3.0 PLUS is intended for patients suffering from periodontal disease.
The AIR-FLOW handy 3.0 PLUS is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment. | The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea. | The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease.
The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. |
| Regulation
Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 |
| Regulation Title | Dental handpiece and accessories | Dental handpiece and accessories | Dental handpiece and accessories | Dental handpiece and accessories |
| Regulation
Class | I | I | I | I |
| Product Code | EFB | EFB | EFB | EFB |
| Device Design | | | | |
| Principles of
Operation | PROPHYflex
ব
The
product is designed to
a cleansing
apply
mixture of air, water
and different powders
to tooth surface in
order
to
remove
plaque and stain. The
product consists of a
stainless
shell
that is
handpiece
attached
to
an
air/water coupling, a
powder reservoir and a
stainless-steel cannula
which
through
the
spray
powder
ાટ
projected onto tooth
surface. | principles
The
of
operation
of
the
proposed PLUS hand-
device
held
are
identical
to
the
predicates PERIO and
STANDARD. Both the
proposed and parent
devices are handheld
devices that connect to
standard
turbine
a
connection on a dental
operative
unit
and
deliver a mixture of
water,
air
and
prophylaxis powder to
a treatment site. | PROPHYflex
2
The
product is designed to
apply
a
cleansing
mixture of air, water
and sodium bicarbonate
to tooth surface in order
to remove plaque and
stain.
The product
consists of a stainless
shell handpiece that is
attached to an air/water
coupling,
a
bicarbonate reservoir
a stainless-steel
and
cannula through which
the sodium bicarbonate
spray is projected onto
tooth surface. | |
| Operational
Modes | Max Mode
●
●
Middle Mode
(reduced mode,
less powder)
Spray-function
●
Mode
(mode
without
powder,
water
only) | Max Mode | Max Mode | |
| Function | Air Polishing | Air Polishing | Air Polishing | Air Polishing |
| Air / water
ports | Internal Spray | Internal Spray | Internal Spray | |
| Fiberoptics | N/A | N/A | N/A | |
| Dimensions | Length (with Nozzle
and Grip Sleeve long):
Up to 190 mm
Height: Up to 84mm
Largest diameter: Up
to 40mm | Length: Up to 200
mm
Height: Up to 110mm
(with MULTIflex-
coupling)
Largest diameter: Up
to 43mm | Length (with Nozzle):
Up to 263 mm
Height: Up to 89mm
Largest diameter: Up
to 38mm | |
| Type of chuck | N/A | N/A | N/A | |
| Coupling
Dimensions | Complies with ISO
7785-1, ISO 14457
and ISO 9168. | Complies with ISO
7785-1, ISO 14457
and ISO 9168. | Complies with ISO
7785-1, ISO 14457,
and ISO 9168. | |
| Accessories /
Compatible
Prophylaxis
Powders
Rotary | PROPHYflex Powder,
PROPHYpearls,
PROPHYflex
Perio
Powder | Perio (Glycine) | PROPHYflex Powder,
PROPHYpearls,
PROPHYflex
Perio
Powder
N/A | |
| Instruments | N/A | N/A | | |
| Composition of Materials | | | | |
| Direct patient-
contacting
portions of the
device | All materials for the
PROPHYflex 4 are
listed in the tables
below including
chemical composition
of the waterlines and
the patient-contacting
portions of the device.
Biocompatible
according to ISO
10993-1 (Biological
evaluation of medical
devices - Part 1:
Evaluation and testing
within a risk
management system). | Biocompatible
according to ISO
10993-1
(Biological evaluation
of medical devices - Part
1: Evaluation and
testing within a risk
management system). | Biocompatible
according to ISO
10993-1
(Biological evaluation of
medical devices - Part
1: Evaluation and
testing within a risk
management system). | |
| Indirect
patient-
contacting
portions of the
device (water /
air lines) | All materials for the
PROPHYflex 4 are
listed in the tables
below including
chemical composition
of the waterlines and
the patient-contacting
portions of the device.
Biocompatible
according to ISO
10993-1 (Biological
evaluation of medical
devices - Part 1:
Evaluation and testing
within a risk
management system). | Biocompatible
according to ISO
10993-1
(Biological evaluation
of medical devices - Part
1: Evaluation and
testing within a risk
management system). | Biocompatible
according to ISO
10993-1
(Biological evaluation of
medical devices - Part
1: Evaluation and
testing within a risk
management system). | |
| Technical Specifications | | | | |
| Chuck Design | N/A | N/A | N/A | |
| Light Intensity | N/A | N/A | N/A | |
| Bur Retention
Force | N/A | N/A | N/A | |
| Bur Extraction
Force | N/A | N/A | N/A | |
| Treatment Site | Supragingival and
Subgingival | Supragingival and
Subgingival | Supragingival | Subgingival |
| Subgingival
usage depth | Up to 5mm | Up to 4mm | N/A | Up to 5mm |
| Transportation
and Storage
Condition -
Temperature | -20 °C to +70 °C (-4
°F to +158 °F) | Storage: +5°C to
+40°C
Transportation: -10°C
to +40°C (ventilated)
or 60°C (non
ventilated) | -20 °C to +70 °C (-4
°F to +158 °F) | |
| Transportation
and Storage
Condition -
Relative
Humidity | 5% RH to 85% RH
absence of
condensation | Storage: 5% to 85%
relative humidity
Transportation: 75%
relative humidity | 5% RH to 85% RH
absence of
condensation | |
| Transportation
and Storage
Condition - Air
Pressure | 700 hPa to 1060 hPa
(10 psi to 15 psi) | Storage: 500 hPa to
1060 hPa air pressure
Transportation: min.
700hPa air pressure | 700 hPa to 1060 hPa
(10 psi to 15 psi) | |
| Noise Level | 56.6 - 69.0 dB(A) | 74.9 dB(A) | 71.6 dB(A) | |
| Temperature
Grip Sleeve | 18,0°C - 25,1°C | 19,93°C - 23,33°C | 21,64°C - 23,59°C | |
| Maximum Air
Pressure | 3.2 - 5 bar (46 - 73
psi) | 2.7 – 3.5 bar (39 – 51
psi ) | 3.2 - 5 bar (46 - 73
psi) | |
| Air and water
supply | 6.4 - 14.3 Nl/min | 10,3 – 13,5 Nl/min | 10,5 – 17,4 NI/min | |
| Maximum
Water Pressure | 1.0 - 2.5 bar (15 - 36
psi ) | 1.0 – 2.2 bar (15 – 32
psi ) | 1.5 - 2.5 bar (22 - 36
psi ) | |
| Air and Water
Supply - Spray
Water | 28 – 54 ml/min | 106 ml/min | 50 ml/min | |
| Speed Range
(RPM's) | N/A | N/A | N/A | |
| Conformance
Standards
(Handpieces
and Motors) | DIN EN ISO 20608
(Dentistry - Powder
jet handpieces and
powders)
DIN 19402 (Powder
Jet Handpieces) | DIN 19402 (Powder
Jet Handpieces) | DIN 19402 (Powder Jet
Handpieces) | |
| Conformance
Standards
(Shanks) | N/A | N/A | N/A | |
| Conformance
Standards
(Coupling
Dimensions) | KaVo MULTIflex-
Coupling,
Sirona Coupling | KaVo MULTIflex-
Coupling,
Sirona Coupling
Midwest 4-hole
connection
NSK coupling
W&H coupling
BienAir-coupling | KaVo MULTIflex-
Coupling,
Sirona Coupling | |
| Conformance
Standards
(Hose
Connections) | Complies with ISO
7785-1, ISO 14457
and ISO 9168. | Complies with ISO
7785-1, ISO 14457
and ISO 9168. | Complies with ISO
7785-1, ISO 14457,
and ISO 9168. | |
| Lubricant | | | | |
| Lubricant | N/A | N/A | N/A | |
7
8
9
10
Non-Clinical Test Data:
Performance bench testing according to international standards for dental handpieces has been conducted to determine conformance in regards to:
- . Biocompatibility has been completed for the applicable components.
- Comparative performance testing of the functions of the integrated accessories as . compared to the cleared stand-a-lone device.
Furthermore, the performance of the PROPHYflex 4 Handpiece and Accessories has been verified utilizing the following standards:
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Including: Amendment 1 (2013)).
- . ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces.
- . ISO 17665-1 First edition 2006-08-15 - Sterilization of health care products - Moist heat - part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- AAMI / ANSI ST79 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive . guide to steam sterilization and sterility assurance in health care facilities.
- . ISO 20608:2017 - Air driven powder jet handpieces and powders
- AAMI / ANSI / ISO 10993-1:2009/(R)2013 - Biological evaluation of medical devices part 1: evaluation and testing within a risk management process.
- . ISO 10993-5 Third edition 2009-06-01 - Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity.
- . ISO 10993-10:2010 (3rd ed) 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-18 First edition 2005-07-01 Chemical characterization of materials ●
- ISO 14971 Second Edition 2007-03-01, Medical Devices Application of risk . management to medical devices.
- . Guidance for Industry and FDA Staff:2007-05-02 - Dental Handpieces - Premarket Notification [510(k)] Submissions
Hence the PROPHYflex 4 Handpiece and Accessories demonstrates substantial equivalence.
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the PROPHYflex 4 Handpiece and Accessories are deemed to be substantially equivalent to the predicate device.
11
Image /page/11/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kaltenbach & Voigt GmbH
April 10, 2019
% Frank Ray Regulatory Affairs Manager KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, North Carolina 28273
Re: K181110
Trade/Device Name: PROPHYflex 4 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFB Dated: March 8, 2019 Received: March 11, 2019
Dear Frank Ray:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
12
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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