(348 days)
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 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.
The provided text is a 510(k) summary for a dental handpiece, the PROPHYflex 4. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical performance testing.
Crucially, this document explicitly states: "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."
Therefore, a study demonstrating the device meets acceptance criteria via clinical performance (which would involve human readers, ground truth established by experts, MRMC studies, etc.) was explicitly not performed and is not required for this type of device according to the provided FDA submission.
However, I can extract the acceptance criteria and reported performance based on the non-clinical (bench) testing, and other relevant information from the document, framing it within the context of a "study" as requested, even if it's a bench study rather than a clinical one.
Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PROPHYflex 4 are implicitly defined by its ability to perform as well as, or better than, its predicate devices across various technical specifications and to comply with relevant international standards. The study proving these criteria are met consists of non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially demonstrated equivalence or improvement over the predicate device (AIR-FLOW Handy 3.0 Plus (K151912)) and compliance with specified ISO standards.
| Feature / Acceptance Criterion (Implicit) | Acceptance Criterion (Specific Value from Predicate or Standard) | Reported Device Performance (PROPHYflex 4) | Met? |
|---|---|---|---|
| Indications for Use (Subgingival) | Non-surgical removal of subgingival plaque in pockets up to 4 mm (Predicate H3.0 Plus), Up to 5mm (Reference Predicate H3.0 PERIO) | Non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. | Yes |
| Max Mode Operation | Present (Predicate H3.0 Plus) | Present | Yes |
| Internal Spray | Present (Predicate H3.0 Plus) | Present | Yes |
| Coupling Dimensions | Complies with ISO 7785-1, ISO 14457, and ISO 9168 (Predicate H3.0 Plus) | Complies with ISO 7785-1, ISO 14457, and ISO 9168. (Specifically mentioning KaVo MULTIflex-Coupling, Sirona Coupling compatibility) | Yes |
| Biocompatibility | According to ISO 10993-1 (Predicate H3.0 Plus) | Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices), ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Irritation/sensitization), ISO 10993-18 (Chemical characterization). | Yes |
| Noise Level | 74.9 dB(A) (Predicate H3.0 Plus) | 56.6 - 69.0 dB(A) (Quieter than predicate) | Yes |
| Operating Temperature (Grip Sleeve) | 19.93°C - 23.33°C (Predicate H3.0 Plus) | 18.0°C - 25.1°C (Wider range, but within acceptable dental operating temperatures) | Yes |
| Maximum Air Pressure | 2.7 – 3.5 bar (39 – 51 psi) (Predicate H3.0 Plus) | 3.2 - 5 bar (46 - 73 psi) (Higher pressure capability) | Yes |
| Air and water supply | 10.3 – 13.5 Nl/min (Predicate H3.0 Plus) | 6.4 – 14.3 Nl/min (Comparable range) | Yes |
| Maximum Water Pressure | 1.0 – 2.2 bar (15 – 32 psi) (Predicate H3.0 Plus) | 1.0 - 2.5 bar (15 - 36 psi) (Higher pressure capability) | Yes |
| Spray Water Flow | 106 ml/min (Predicate H3.0 Plus) | 28 – 54 ml/min (Lower flow, noted as a difference but not raising new concerns) | Yes |
| Compliance with Powder Jet Handpiece Standard | DIN 19402 (Predicate H3.0 Plus) | DIN EN ISO 20608 (Dentistry - Powder jet handpieces and powders), DIN 19402 (Powder Jet Handpieces) | Yes |
| Additional Operational Modes | N/A (Predicate H3.0 Plus only has Max Mode) | Middle Mode (reduced powder), Spray-function Mode (water only) | N/A (Improvement over predicate) |
| Device Dimensions (Length) | 200 mm (Predicate H3.0 Plus) | Up to 190 mm (10 mm shorter) | Yes |
| Device Dimensions (Largest Diameter) | 43 mm (Predicate H3.0 Plus) | Up to 40 mm (3 mm thinner) | Yes |
| Reprocessing Method | N/A (Standard dental practice) | Components are to be completely reprocessed after each use (standard for dental handpieces) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact "sample sizes" in terms of number of devices tested for each bench test. These are typically covered under the manufacturer's internal quality system documentation and test protocols, which are summarized rather than detailed in a 510(k). The tests are performed on representative units of the device.
- Data Provenance: The testing was non-clinical (bench testing).
- Country of Origin: The manufacturer is Kaltenbach & Voigt GmbH, located in Biberach, Germany. Therefore, the testing would likely have been conducted in Germany or by approved testing facilities.
- Retrospective or Prospective: This refers to the collection of patient data, not bench testing. Bench testing is inherently prospective in its execution, demonstrating performance against specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
- This question is not applicable as the study was purely non-clinical bench testing. There were no "experts" establishing a clinical "ground truth" for a test set, as no clinical test set involving human subjects was used. The "ground truth" for bench testing is derived from engineering specifications, established medical device safety and performance standards (e.g., ISO standards), and comparative performance against legally marketed predicate devices.
4. Adjudication Method for the Test Set
- This question is not applicable as there was no test set requiring human expert adjudication (e.g., image interpretation). Bench testing results are typically objectively measured against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "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." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable in the context of a dental handpiece. The device is a physical instrument, not an AI algorithm. Its "performance" is its mechanical, fluidic, and material characteristics demonstrated through bench testing.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance validation is based on:
- International Standards: Compliance with ISO standards (e.g., ISO 7785-1, ISO 14457, ISO 9168, ISO 10993 series, ISO 20608).
- Predicate Device Performance: Demonstrating that the PROPHYflex 4's performance characteristics (dimensions, noise, pressure, flow, etc.) are comparable to or improved over the legally marketed predicate device (AIR-FLOW Handy 3.0 Plus (K151912)) and other reference devices.
- Engineering Specifications: Internal design specifications and performance targets set by the manufacturer for the device.
8. The Sample Size for the Training Set
- This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as this is a physical medical device, not an AI/ML algorithm; therefore, there is no "training set" or "ground truth" establishment for it in this context.
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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)
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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.
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.
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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 /Accessory | Device Description | Manufacturer | Product Code | 510(k) Clearance |
| PROPHYflexPowder - Orange | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflexPowder - Berry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflexPowder - Cherry | Oral cavity abrasive polishing agent | Kaltenbach and Voigt GmbH | EJR | Exempt |
| PROPHYflexPowder - 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 |
| PROPHYflexPerio 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 | ||||
|---|---|---|---|---|
| DescriptiveInformation | Proposed DevicePROPHYflex 4 andAccessories | Predicate DeviceAIR-FLOW Handy3.0 Plus (K151912) | Reference Device #2PROPHYflex 2 andAccessories(K973876) | ReferencePredicate #1AIR-FLOW handy3.0 PERIO(K132480) |
| Indications for Use | ||||
| Indications forUse | 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. |
| RegulationNumber | 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 |
| RegulationClass | I | I | I | I |
| Product Code | EFB | EFB | EFB | EFB |
| Device Design | ||||
| Principles ofOperation | PROPHYflexবTheproduct is designed toa cleansingapplymixture of air, waterand different powdersto tooth surface inordertoremoveplaque and stain. Theproduct consists of astainlessshellthat ishandpieceattachedtoanair/water coupling, apowder reservoir and astainless-steel cannulawhichthroughthespraypowderાટprojected onto toothsurface. | principlesTheofoperationoftheproposed PLUS hand-deviceheldareidenticaltothepredicates PERIO andSTANDARD. Both theproposed and parentdevices are handhelddevices that connect tostandardturbineaconnection on a dentaloperativeunitanddeliver a mixture ofwater,airandprophylaxis powder toa treatment site. | PROPHYflex2Theproduct is designed toapplyacleansingmixture of air, waterand sodium bicarbonateto tooth surface in orderto remove plaque andstain.The productconsists of a stainlessshell handpiece that isattached to an air/watercoupling,abicarbonate reservoira stainless-steelandcannula through whichthe sodium bicarbonatespray is projected ontotooth surface. | |
| OperationalModes | Max Mode●●Middle Mode(reduced mode,less powder)Spray-function●Mode(modewithoutpowder,wateronly) | Max Mode | Max Mode | |
| Function | Air Polishing | Air Polishing | Air Polishing | Air Polishing |
| Air / waterports | Internal Spray | Internal Spray | Internal Spray | |
| Fiberoptics | N/A | N/A | N/A | |
| Dimensions | Length (with Nozzleand Grip Sleeve long):Up to 190 mmHeight: Up to 84mmLargest diameter: Upto 40mm | Length: Up to 200mmHeight: Up to 110mm(with MULTIflex-coupling)Largest diameter: Upto 43mm | Length (with Nozzle):Up to 263 mmHeight: Up to 89mmLargest diameter: Upto 38mm | |
| Type of chuck | N/A | N/A | N/A | |
| CouplingDimensions | Complies with ISO7785-1, ISO 14457and ISO 9168. | Complies with ISO7785-1, ISO 14457and ISO 9168. | Complies with ISO7785-1, ISO 14457,and ISO 9168. | |
| Accessories /CompatibleProphylaxisPowdersRotary | PROPHYflex Powder,PROPHYpearls,PROPHYflexPerioPowder | Perio (Glycine) | PROPHYflex Powder,PROPHYpearls,PROPHYflexPerioPowderN/A | |
| Instruments | N/A | N/A | ||
| Composition of Materials | ||||
| Direct patient-contactingportions of thedevice | All materials for thePROPHYflex 4 arelisted in the tablesbelow includingchemical compositionof the waterlines andthe patient-contactingportions of the device.Biocompatibleaccording to ISO10993-1 (Biologicalevaluation of medicaldevices - Part 1:Evaluation and testingwithin a riskmanagement system). | Biocompatibleaccording to ISO10993-1(Biological evaluationof medical devices - Part1: Evaluation andtesting within a riskmanagement system). | Biocompatibleaccording to ISO10993-1(Biological evaluation ofmedical devices - Part1: Evaluation andtesting within a riskmanagement system). | |
| Indirectpatient-contactingportions of thedevice (water /air lines) | All materials for thePROPHYflex 4 arelisted in the tablesbelow includingchemical compositionof the waterlines andthe patient-contactingportions of the device.Biocompatibleaccording to ISO10993-1 (Biologicalevaluation of medicaldevices - Part 1:Evaluation and testingwithin a riskmanagement system). | Biocompatibleaccording to ISO10993-1(Biological evaluationof medical devices - Part1: Evaluation andtesting within a riskmanagement system). | Biocompatibleaccording to ISO10993-1(Biological evaluation ofmedical devices - Part1: Evaluation andtesting within a riskmanagement system). | |
| Technical Specifications | ||||
| Chuck Design | N/A | N/A | N/A | |
| Light Intensity | N/A | N/A | N/A | |
| Bur RetentionForce | N/A | N/A | N/A | |
| Bur ExtractionForce | N/A | N/A | N/A | |
| Treatment Site | Supragingival andSubgingival | Supragingival andSubgingival | Supragingival | Subgingival |
| Subgingivalusage depth | Up to 5mm | Up to 4mm | N/A | Up to 5mm |
| Transportationand StorageCondition -Temperature | -20 °C to +70 °C (-4°F to +158 °F) | Storage: +5°C to+40°CTransportation: -10°Cto +40°C (ventilated)or 60°C (nonventilated) | -20 °C to +70 °C (-4°F to +158 °F) | |
| Transportationand StorageCondition -RelativeHumidity | 5% RH to 85% RHabsence ofcondensation | Storage: 5% to 85%relative humidityTransportation: 75%relative humidity | 5% RH to 85% RHabsence ofcondensation | |
| Transportationand StorageCondition - AirPressure | 700 hPa to 1060 hPa(10 psi to 15 psi) | Storage: 500 hPa to1060 hPa air pressureTransportation: 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) | |
| TemperatureGrip Sleeve | 18,0°C - 25,1°C | 19,93°C - 23,33°C | 21,64°C - 23,59°C | |
| Maximum AirPressure | 3.2 - 5 bar (46 - 73psi) | 2.7 – 3.5 bar (39 – 51psi ) | 3.2 - 5 bar (46 - 73psi) | |
| Air and watersupply | 6.4 - 14.3 Nl/min | 10,3 – 13,5 Nl/min | 10,5 – 17,4 NI/min | |
| MaximumWater Pressure | 1.0 - 2.5 bar (15 - 36psi ) | 1.0 – 2.2 bar (15 – 32psi ) | 1.5 - 2.5 bar (22 - 36psi ) | |
| Air and WaterSupply - SprayWater | 28 – 54 ml/min | 106 ml/min | 50 ml/min | |
| Speed Range(RPM's) | N/A | N/A | N/A | |
| ConformanceStandards(Handpiecesand Motors) | DIN EN ISO 20608(Dentistry - Powderjet handpieces andpowders)DIN 19402 (PowderJet Handpieces) | DIN 19402 (PowderJet Handpieces) | DIN 19402 (Powder JetHandpieces) | |
| ConformanceStandards(Shanks) | N/A | N/A | N/A | |
| ConformanceStandards(CouplingDimensions) | KaVo MULTIflex-Coupling,Sirona Coupling | KaVo MULTIflex-Coupling,Sirona CouplingMidwest 4-holeconnectionNSK couplingW&H couplingBienAir-coupling | KaVo MULTIflex-Coupling,Sirona Coupling | |
| ConformanceStandards(HoseConnections) | Complies with ISO7785-1, ISO 14457and ISO 9168. | Complies with ISO7785-1, ISO 14457and ISO 9168. | Complies with ISO7785-1, ISO 14457,and ISO 9168. | |
| Lubricant | ||||
| Lubricant | N/A | N/A | N/A |
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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.
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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
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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
§ 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.