K Number

Device Name

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)

Manufacturer

Kettenbach GmbH & Co. KG

Date Cleared

2023-07-24

(167 days)

Product Code

LBH PRO

Regulation Number

872.3260

Intended Use

Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Device Description

Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092141

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a fluoride varnish, a chemical substance applied to teeth. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on biocompatibility and physical properties, not algorithmic performance.

Therapeutic

Yes
The device is intended for "mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity," which constitutes a therapeutic action.

Diagnostic

The device is a fluoride varnish used for treatment (mechanical occlusion of dentinal tubules for tooth hypersensitivity), not for diagnosing a condition.

SaMD (Software as a Medical Device)

The device is a physical substance (varnish) applied to teeth, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity." This describes a direct therapeutic action on the patient's body (the teeth), not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The description focuses on the physical properties and application of the varnish to the tooth surface.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Profisil® Fluoride Varnish is applied in vivo (on the body) for a therapeutic effect.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Product codes (comma separated list FDA assigned to the subject device)

LBH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dentinal tubules, tooth, enamel, dentin

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)

The following performance data were provided in support of the substantial equivalence determination. The biocompatibility evaluation for Profisil® Fluoride Varnish was conducted in accordance with ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.:

Cytotoxicity ISO 10993-5
Sensitization ISO 10993-10
Irritation ISO 10993-23
Pyrogenicity ISO 10993-11
Systemic toxicity ISO 10993-11
To evaluate the biological safety of Kettenbach's Fluoride Varnish, consideration was given to the type of patient contact, the potential hazards associated with the chemicals used in the devices, and historical use of the materials used in the devices. Profisil® Fluoride Varnish is considered to have met the requirements of ISO 10993-1:2018, ISO 7405:2018, FDA's Use of International standard ISO 10993-1, and the European Union Medical Regulation (EU) 2017/745 is an externally communicating device with limited (

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 24, 2023

Kettenbach GmbH & Co. KG Katja Simon Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, Hessen 35713 GERMANY

Re: K230333

Trade/Device Name: Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)

Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: June 22, 2023 Received: June 22, 2023

Dear Katja Simon:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K230333

Device Name

Profisil Fluoride Varnish Combi pack (14801);

Profisil Fluoride Varnish Normal pack mint (14802);

Profisil Fluoride Varnish Normal pack berry (14804);

Profisil Fluoride Varnish Normal pack unflavored (14806);

Profisil Fluoride Varnish Sample pack (14800)

Indications for Use (Describe)

Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

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/3/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features a graphic of six circles arranged in a triangular shape, with the company name "KETTENBACH DENTAL" written in a sans-serif font below it. Underneath the company name, the tagline "Simply intelligent" is written in a smaller font.

510(k) Summary - K230333

l. Submitter:

Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany

Phone: +49 2774 705 0 Fax: +49 2774 705 66

Contact person:

Simon, Katja Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: katja.simon@kettenbach.com

Date of preparation:

July 24th, 2023

II. Device

Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Product Code:

Profisil® Fluoride Varnish Profisil® Fluoride Varnish Dental, Varnish, Cavity (21 CFR 872.3260) = LBH

Image /page/4/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of six blue circles arranged in a pyramid shape above the company name. Below the company name is the tagline "Simply intelligent".

. Predicate devices:

Vanish™ Varnish (3M Espe), K092141 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. Device Description:

V. Indications for Use:

Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Image /page/5/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of a triangular arrangement of six blue circles above the text "KETTENBACH DENTAL", with the word "DENTAL" in a slightly lighter shade of blue. Below the company name is the tagline "Simply intelligent" in a smaller font size.

Table 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

	Predicate Devices	Substantial Equivalent Device	Conclusion
Product	Vanish Varnish	Profisil®
Manufacturer	3M Espe	Kettenbach GmbH & Co. KG
Product
Description	3M™ ESPE™ Vanish™ Varnish 5%
Sodium Fluoride White Varnish is a
22.600 ppm fluoride-containing varnish for
application to enamel and dentin for the
treatment of hypersensitivity teeth. It will
spread on and adhere to moist teeth.
Vanish varnish is an alcohol-based
solution of modified rosin. The product is
sweetened with xylitol. Vanish varnish
contains an innovative tri-calcium
phosphate (TCP) ingredient exclusively
from 3M. The ingredient TCP serves as a
source of bioavailable calcium and
phosphate ions when the varnish is
applied to the teeth. Calcium and
phosphate ions are naturally occurring
components of saliva long associated with
maintaining healthy teeth.	Profisil® Fluoride Varnish is designed to
securely adhere to the tooth surface for
several hours while releasing fluoride
ions. The varnish contains 5 % sodium
fluoride suspended in a mucosa-friendly,
pleasantly flavored dimethicone gel. The
varnish is available in following versions:
mint, berry and unflavored.	Treatment of
hypersensitivity teeth is the
technological principle for
both the subject and
predicate devices. The
content of sodium fluoride
is identical.
The following differences
exist between the subject
and the predicate device:
Profisil® does not contain
TCP
Intended purpose	5% Sodium Fluoride Varnish for the
treatment of dentinal hypersensitivity	5% Sodium Fluoride Varnish indicated
for the treatment of dentinal
hypersensitivity.	The intended purpose is
identical
Indication	• Treatment of hypersensitive teeth
• Use on exposed dentin and root
sensitivity
• Under temporary restoratives and
cements where post-operative sensitivity
is of concern	Profisil® Fluoride Varnish is a 5 %
sodium fluoride varnish which produces
mechanical occlusion of the dentinal
tubules in the treatment of tooth
hypersensitivity.	The indication is the same
and are intended for the
same general population of
patients, experiencing
dentinal hypersensitivity.
Both devices produce an
occlusion of the dentinal
tubules in the treatment of
tooth hypersensitivity.
Basic formulation	• Colophony / Polyamide resin
• Ethyl alcohol
• Flavor
• 5% Sodium fluoride	• Silicone Encapsulant
• Thickener/ Adhesive
• Flavor / Sweetener
• 5% Sodium fluoride	The percentage of sodium
fluoride is identical.
However, Profisil does not
contain TCP
	Predicate Devices	Substantial Equivalent Device	Conclusion
Product	Vanish Varnish	Profisil®
Manufacturer	3M Espe	Kettenbach GmbH & Co. KG
Mode of action /
technology	Dentin tubule occlusion
The material acts to physically block or
occlude patent/open dentin tubules on the
dentition. Vanish Varnish has unit-dose
packages delivering up to 0.25 mL to 0.4
mL of 5% sodium fluoride.
However, this product contains
substances that may cause an allergic
reaction by skin contact in certain
individuals.	Dentin tubule occlusion
The material acts to physically block or
occlude patent/open dentin tubules on
the dentition.	Same mode of action.
Single use	Single use only	Single use only	Identical, both are single
use devices
Method of
application	Unit-dose packages delivering up to 0.25
ml or 0.4ml of 5% sodium fluoride varnish.
Varnish and an applicator brush placed in
a molded tray and closed with a seal	Unit-dose packages delivering in 0.5ml
of 5% sodium fluoride varnish. Varnish
and an applicator brush placed in a
molded tray and closed with a seal	The delivery systems and
the mode of application are
similar.
Contraindications /
Precautions	This product contains substances that
may cause an allergic reaction by skin
contact in certain individuals. Avoid use of
this product in patients with known
colophony allergies. Discontinue patient's
use of other prescriptive fluoride
preparations for 24 hours following Vanish
Varnish 5% sodium fluoride varnish
application. Children taking fluoride
supplements should discontinue for 1-3
days following treatment.	Do not use this product on any individual
who has a known intolerance to fluoride.
If any signs of inflammation or allergic
reaction occur, discontinue use
immediately and refrain from further use
with this patient.
Other prescription products containing
fluoride should not be used within 24
hours of using the varnish.
Patients using regular, systemic
fluoridation should stop using these
products for three days following use of
this varnish	Discontinue patient's use of
other prescriptive fluoride
preparations for 24 hours /
three days is similar
Shelf Life	24 months	24 months	The shelf life is identical
Performance
testing	A comparison of the parameters in respect, pH value, dynamic viscosity, fluoride release and electron microscopy
(SEM) studies were performed. The results demonstrated the substantial equivalence to the predicate device.
Summary of
Product
Description,	The indication of the subject device is the same for the predicate device. Contraindications, application, and side
effects for both products are basically the same - there is a slight difference in the wording.
	Predicate Devices	Substantial Equivalent Device	Conclusion
Product	Vanish Varnish	Profisil®
Manufacturer	3M Espe	Kettenbach GmbH & Co. KG
Intended purpose
Indications,
Contraindications /
Precautions
Summary
Chemical
Composition	The Profisil® formulation has been thoroughly assessed for biocompatibility.
Summary of
Finished
Device
Specification	According to EN ISO 17730:2020 "Dentistry - fluoride varnishes" apart from the total fluoride, no other properties
appear as being relevant for having the device functioning or performing as intended.
Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2020 –
Dentistry- fluoride varnishes".
The acceptance criteria of EN ISO 17730:2020 was fulfilled.

Image /page/6/Picture/0 description: The image features the logo for KETTENBACH DENTAL. Above the company name, there is a graphic of six circles arranged in a triangular pattern. Below the company name, the words "Simply intelligent" are written in a smaller font.

Image /page/7/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of six blue circles arranged in a triangular formation above the text "KETTENBACH DENTAL". Below the company name is the tagline "Simply intelligent" in a smaller font size. The overall design is clean and professional, suggesting a focus on innovation and simplicity.

Image /page/8/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue graphic of six circles arranged in a triangular shape above the company name. The text "KETTENBACH DENTAL" is written in blue, with the word "DENTAL" in a slightly lighter shade. Below the company name is the tagline "Simply intelligent" in a smaller, lighter blue font.

VII. Performance Data:

Biocompatibility:

· Cytotoxicity ISO 10993-5
· Sensitization ISO 10993-10
Irritation ISO 10993-23
Pyrogenicity ISO 10993-11
· Systemic toxicity ISO 10993-11

To evaluate the biological safety of Kettenbach's Fluoride Varnish, consideration was given to the type of patient contact, the potential hazards associated with the chemicals used in the devices, and historical use of the materials used in the devices. Profisil® Fluoride Varnish is considered to have met the requirements of ISO 10993-1:2018, ISO 7405:2018, FDA's Use of International standard ISO 10993-1, and the European Union Medical Regulation (EU) 2017/745 is an externally communicating device with limited (