PROPHYflex 4

K181110 · Kaltenbach & Voigt GmbH · EFB · Apr 10, 2019 · Dental

Device Facts

• Record ID: K181110
• Device Name: PROPHYflex 4
• Applicant: Kaltenbach & Voigt GmbH
• Product Code: EFB · Dental
• Decision Date: Apr 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

Air polishing dental handpiece; projects mixture of water, air, and prophylaxis powders (sodium bicarbonate, calcium carbonate, or glycine) onto tooth surfaces. Connects to dental unit via KaVo MULTIflex or Sirona coupler. User fills powder container; foot control activates air flow to swirl and transport powder to cannula tip. Features three adjustable powder levels (Max, Middle, Spray-only). Used by dental professionals in clinical settings for biofilm management, stain removal, and surface preparation. Provides gentle, even cleaning; adjustable spray settings allow customization based on clinical needs. Benefits include efficient plaque/stain removal and improved access to subgingival areas.

Clinical Evidence

No clinical data. Substantial equivalence established through bench testing, including biocompatibility (ISO 10993-1, -5, -10, -18), performance verification against ISO 20608, and mechanical testing of hose connectors and sterilization processes.

Technological Characteristics

Air-driven powder jet handpiece; stainless steel shell; powder reservoir; interchangeable cannulas. Connects via ISO 7785-1/14457/9168 compliant couplers. Operates on air/water supply from dental unit. Sterilization via moist heat (ISO 17665-1). Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients requiring supragingival and subgingival prophylaxis, including removal of soft deposits, discoloration, plaque, and preparation for dental procedures (fillings, veneers, orthodontic appliances). Subgingival use indicated for pockets up to 5 mm after initial periodontal treatment.

Regulatory Classification

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.

Predicate Devices

• AIR-FLOW Handy 3.0 Plus (K151912)

Reference Devices

• AIR-FLOW handy 3.0 PERIO (K132480)
• PROPHYflex 2 (K973876)
• SMARTmatic (K163239)
• ELECTROmatic (K163317)

Submission Summary (Full Text)

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#### 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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.

K181110

Section V - 510(k) Summary for PROPHYflex 4

### Handpiece and Accessories

- 1. Submitter Information:
Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Germany

| Contact Person: | Frank Ray |
|-------------------|----------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

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

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## 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.

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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.

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| Table 5.2 | | | | |
|-------------------------------|--------------------------------------|---------------------------|--------------|------------------|
| Device /<br>Accessory | Device Description | Manufacturer | Product Code | 510(k) Clearance |
| PROPHYflex<br>Powder - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex<br>Powder - Berry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex<br>Powder - Cherry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflex<br>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<br>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.

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#### 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.

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# Device Comparison Table:

# Table 5.3

| Table 5.3 | | | | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Descriptive<br>Information | Proposed Device<br>PROPHYflex 4 and<br>Accessories | Predicate Device<br>AIR-FLOW Handy<br>3.0 Plus (K151912) | Reference Device #2<br>PROPHYflex 2 and<br>Accessories<br>(K973876) | Reference<br>Predicate #1<br>AIR-FLOW handy<br>3.0 PERIO<br>(K132480) |
| Indications for Use | | | | |
| Indications for<br>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.<br><br>The AIR-FLOW handy 3.0 PLUS is intended for patients suffering from periodontal disease.<br><br>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.<br><br>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<br>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<br>Class | I | I | I | I |
| Product Code | EFB | EFB | EFB | EFB |
| Device Design | | | | |
| Principles of<br>Operation | PROPHYflex<br>ব<br>The<br>product is designed to<br>a cleansing<br>apply<br>mixture of air, water<br>and different powders<br>to tooth surface in<br>order<br>to<br>remove<br>plaque and stain. The<br>product consists of a<br>stainless<br>shell<br>that is<br>handpiece<br>attached<br>to<br>an<br>air/water coupling, a<br>powder reservoir and a<br>stainless-steel cannula<br>which<br>through<br>the<br>spray<br>powder<br>ાટ<br>projected onto tooth<br>surface. | principles<br>The<br>of<br>operation<br>of<br>the<br>proposed PLUS hand-<br>device<br>held<br>are<br>identical<br>to<br>the<br>predicates PERIO and<br>STANDARD. Both the<br>proposed and parent<br>devices are handheld<br>devices that connect to<br>standard<br>turbine<br>a<br>connection on a dental<br>operative<br>unit<br>and<br>deliver a mixture of<br>water,<br>air<br>and<br>prophylaxis powder to<br>a treatment site. | PROPHYflex<br>2<br>The<br>product is designed to<br>apply<br>a<br>cleansing<br>mixture of air, water<br>and sodium bicarbonate<br>to tooth surface in order<br>to remove plaque and<br>stain.<br>The product<br>consists of a stainless<br>shell handpiece that is<br>attached to an air/water<br>coupling,<br>a<br>bicarbonate reservoir<br>a stainless-steel<br>and<br>cannula through which<br>the sodium bicarbonate<br>spray is projected onto<br>tooth surface. | |
| Operational<br>Modes | Max Mode<br>●<br>●<br>Middle Mode<br>(reduced mode,<br>less powder)<br>Spray-function<br>●<br>Mode<br>(mode<br>without<br>powder,<br>water<br>only) | Max Mode | Max Mode | |
| Function | Air Polishing | Air Polishing | Air Polishing | Air Polishing |
| Air / water<br>ports | Internal Spray | Internal Spray | Internal Spray | |
| Fiberoptics | N/A | N/A | N/A | |
| Dimensions | Length (with Nozzle<br>and Grip Sleeve long):<br>Up to 190 mm<br>Height: Up to 84mm<br>Largest diameter: Up<br>to 40mm | Length: Up to 200<br>mm<br>Height: Up to 110mm<br>(with MULTIflex-<br>coupling)<br>Largest diameter: Up<br>to 43mm | Length (with Nozzle):<br>Up to 263 mm<br>Height: Up to 89mm<br>Largest diameter: Up<br>to 38mm | |
| Type of chuck | N/A | N/A | N/A | |
| Coupling<br>Dimensions | Complies with ISO<br>7785-1, ISO 14457<br>and ISO 9168. | Complies with ISO<br>7785-1, ISO 14457<br>and ISO 9168. | Complies with ISO<br>7785-1, ISO 14457,<br>and ISO 9168. | |
| Accessories /<br>Compatible<br>Prophylaxis<br>Powders<br>Rotary | PROPHYflex Powder,<br>PROPHYpearls,<br>PROPHYflex<br>Perio<br>Powder | Perio (Glycine) | PROPHYflex Powder,<br>PROPHYpearls,<br>PROPHYflex<br>Perio<br>Powder<br>N/A | |
| Instruments | N/A | N/A | | |
| Composition of Materials | | | | |
| Direct patient-<br>contacting<br>portions of the<br>device | All materials for the<br>PROPHYflex 4 are<br>listed in the tables<br>below including<br>chemical composition<br>of the waterlines and<br>the patient-contacting<br>portions of the device.<br>Biocompatible<br>according to ISO<br>10993-1 (Biological<br>evaluation of medical<br>devices - Part 1:<br>Evaluation and testing<br>within a risk<br>management system). | Biocompatible<br>according to ISO<br>10993-1<br>(Biological evaluation<br>of medical devices - Part<br>1: Evaluation and<br>testing within a risk<br>management system). | Biocompatible<br>according to ISO<br>10993-1<br>(Biological evaluation of<br>medical devices - Part<br>1: Evaluation and<br>testing within a risk<br>management system). | |
| Indirect<br>patient-<br>contacting<br>portions of the<br>device (water /<br>air lines) | All materials for the<br>PROPHYflex 4 are<br>listed in the tables<br>below including<br>chemical composition<br>of the waterlines and<br>the patient-contacting<br>portions of the device.<br>Biocompatible<br>according to ISO<br>10993-1 (Biological<br>evaluation of medical<br>devices - Part 1:<br>Evaluation and testing<br>within a risk<br>management system). | Biocompatible<br>according to ISO<br>10993-1<br>(Biological evaluation<br>of medical devices - Part<br>1: Evaluation and<br>testing within a risk<br>management system). | Biocompatible<br>according to ISO<br>10993-1<br>(Biological evaluation of<br>medical devices - Part<br>1: Evaluation and<br>testing within a risk<br>management system). | |
| Technical Specifications | | | | |
| Chuck Design | N/A | N/A | N/A | |
| Light Intensity | N/A | N/A…