Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and physical properties of a fluoride varnish, with no mention of AI or ML.

Therapeutic

Yes.
The "Intended Use" explicitly states that the device is "For treatment of dentinal hypersensitivity," which indicates a therapeutic purpose.

Diagnostic

No

Explanation: The "Intended Use" states that the device is for "treatment of dentinal hypersensitivity," and the "Device Description" explains that it "seals exposed dentin tubules." There is no indication that the device performs any diagnostic function; its purpose is solely therapeutic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a cavity varnish containing physical components (sodium fluoride, rosin) and is applied to teeth, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces." This describes a therapeutic treatment applied directly to the patient's teeth.
Device Description: The description details a cavity varnish applied to teeth to seal exposed dentin tubules. This is a topical application for a therapeutic effect.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.

The device is a medical device, specifically a dental varnish, but it falls under the category of therapeutic devices rather than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces

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

LBH

Device Description

V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dentin, enamel, oral mucosa, teeth, root surfaces

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professional

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)

Non-Clinical Performance Testing:

Study Type: In vitro testing, stability testing, biocompatibility evaluation.
Sample Size: Not specified.
Key Results:
- In vitro testing compared V-varnish™ Premium and the predicate device (Enamel Pro® Varnish) for consistency, pH, fluoride content, and dentinal tubule occlusion.
  - Consistency: Subject Device = 27.14 ± 0.62 mm; Predicate Device = 33.25 ± 0.64 mm
  - pH: Subject Device = 6.65; Predicate Device = 6.69
  - Fluoride content: Subject Device = 2.15 ± 0.03 %; Predicate Device = 1.97 ± 0.05 %
  - Dentinal tubule occlusion: Subject Device = 85%; Predicate Device = 77%
  - The report concludes that "According to bench test result, the physical & performance properties of the subjective device and predicate device are substantial equivalent."
- Stability testing confirmed a shelf life of 24 months at room temperature by evaluating physical properties.
- Biocompatibility evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1, including tests for cytotoxicity (MTT), genotoxicity, oral mucous irritation, sensitization (LLNA), and acute systemic toxicity. Both devices are considered biocompatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Consistency: 27.14 ± 0.62 mm
pH: 6.65
Fluoride content: 2.15 ± 0.03 %
Dentinal tubule occlusion: 85%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062683

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, with flowing lines connecting them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

Vericom Co., Ltd. Myung-Hwan Oh R&d Director 48 Toegyegongdan 1-gil, Chuncheon-si, 200-944 KR

Re: K160377

Trade/Device Name: V-varnish™ Premium Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: November 1, 2016 Received: November 4, 2016

Dear Myung-Hwan Oh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809) medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K160377

Device Name

V-varnish™ Premium

Indications for Use (Describe)

· For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY K160377

V-varnish™ Premium

Date:

I. SUBMITTER

Veriocm Co., Ltd. 48 Toegyegongdan 1-gil, Chuncheon-si, Gangwon-do 200-944, Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883

Contact Name: Myung-Hwan Oh Email: omh@vericom.co.kr

II. DEVICE

Name of Device:	V-varnish™ Premium
Regulation Name:	Cavity Varnish
Classification Name:	Cavity Varnish
Regulatory Class:	II
Product Code:	LBH

III. PREDICATE DEVICE

K062683, Enamel Pro Varnish, PREMIER DENTAL PRODUCTS CO.

IV. DEVICE DESCRIPTION

V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal

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hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.

V. INDICATIONS FOR USE

For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
			Subject Device	Predicate Device	Summary
Device Name			V-varnish™ Premium	Enamel Pro Varnish	-
Manufacturer			VERICOM CO., LTD.	PREMIER DENTAL
PRODUCTS CO.	-
510(k) Number			K160377	K062683	-
Intended user			Dental professional	Dental professional	Same
Similarity	Description		V-varnish™ Premium is cavity
varnish containing 5% sodium
fluoride(F ion: 22,600ppm). It
is applied to teeth for the
purpose of treatment dentinal
hypersensitivity. V-varnish™
Premium consists of rosin
which adheres to the surface
of the teeth, seals exposed
dentin tubules. V-varnish™
Premium has four flavors such
as bubblegum, strawberry,
melon and mint and two
colors(clear and white). It is	Enamel Pro Varnish is a 5%
sodium fluoride varnish
which has a strong
desensitizing action when
applied to enamel and
dentin surfaces. Enamel
Pro Varnish may be used
on moist teeth and leaves
a film of varnish which
sets in the mouth to allow
for visual control and
verification of application.	Description of
subject device
and predicate
device is very
similar;
containing 5%
sodium fluoride,
purpose of use,
fundamental
technology etc.
Subject device
includes more
information
about flavor,
			packed in single dose package
allows easy mixing and
application.		color and
packaging.
	Indication
for Use		For treatment of dentinal
hypersensitivity secondary to
exposed dentin and root
surfaces	Enamel Pro® Varnish is a
fluoride containing
preparation for the
treatment of dentinal
hypersensitivity, and for
the reduction of post
operative sensitivity. The
varnish can be placed on
sensitive root surfaces and
under temporary
restoratives and cements
in order to seal exposed
dentinal tissue. It can be
used as a cavity liner.	Both devices
are used for
treatment of
dentinal
hypersensitivity.
But predicate
device is used
extensively
more subject
device.
Design			Blister packaging
(Varnish + Brush)	Blister packaging
(Varnish + Brush)	Both devices
provide varnish
and brush in
plastic case.
Similarity	Che
mic
al
Composition	Base
mate
rials
&
blocki
ng
denti
nal
tubul	Rosin
Sodium fluoride
Tricalcium phosphate	Rosin
Sodium fluoride
Dibasic Sodium Phosphate
Calcium Sulfate Dihydrate	Both devices
consist of rosin,
ethanol and
sodium fluoride
mainly. Other
components are
additives for
taste, flavour
and colour etc.
		e
		Solve
nt	Ethanol	Ethanol
		Etc.	Sweetener
Pigment
Flavor etc.	etc.
		Recommend
ed
contact time	For at least 4-6 hours	For approximately 4-6 hours	Both devices
remain on the
teeth for at
least 4-6 hours.
		Physical and
performance properties	- Consistency : $27.14\pm0.62$ mm

pH: 6.65
Fluoride content:
$2.15\pm0.03$ %
Dentinal tubule occlusion: 85% | - Consistency: $33.25\pm0.64$ mm
pH: 6.69
Fluoride content :
$1.97\pm0.05$ %
Dentinal tubule
occlusion: 77% | According to
bench test
result, the
physical &
performance
properties of
the subjective
device and
predicate device
are substantial
equivalent. |
| | Bio-
compatibility | | Cytotoxicity
Oral mucosa irritation
Sensitization(LLNA)
Genotoxicity(Ames)
Acute systemic toxicity | Device is biocompatible
when used as directed by
dental professionals per
ISO 10993-1. | Both devices
are
biocompatible |
| | | Sterilization | Non-sterile | Non-sterile | Same |
| | | Shelf Life | 2 years | 2 years | Same |
| Difference | Flavor | | Bubblegum, Strawberry,
Melon,
Mint | VanillaMint,
Strawberrier'n Cream,
Bubblegum | Flavor is an
option that is
selected
according to
patient's taste.
These
differences do
not raise
concerns or
questions when
comparing the
subject device
to the predicate
device. |
| | Storage
condition | | Do not store at elevated
temperature or intense light.
Do not use after expiry date.
Temperature limitation: 0-
30°C (32-86°F) | Keep out of direct
sunlight, store at room
temperature: 68-77°F (20-
25°C). Do not use after
expiration date. | It is a condition
of storage that is
provided from
manufacturer
for stable use
during shelf life.
These
differences do |
| | | | | questions when
comparing the
subject device to
the predicate
device. | |
| | | | | | |

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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VII. NON-CLINICAL PERFORMANCE TESTING

In vitro testing was conducted with V-varnish™ Premium and the predicate device, Enamel Pro® Varnish. Properties evaluated include consistency, pH, fluoride content and dentinal tubule occlusion.

Stability testing was conducted by evaluating the physical properties of the device to confirm a shelf life at room temperature of 24 months.

The biocompatibility evaluation for the V-varnish™ Premium was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, 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. The tests carried out for the devices and standards applied for each test are:

· Cytotoxicity(MTT), ISO 10993-5[2009]
· Genotoxicity, ISO 10993-3[2003]
. Oral mucous Irritation, ISO 10993-10[2010]
. Sensitization(LLNA), ISO 10993-10[2010]
. Acute systemic toxicity, ISO 10993-11[2006]

V-varnish™ Premium is considered to be in contact with dentin, enamel and oral mucosa for duration of less than 24 hours, while being the external communicating device.

VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject device is similar to indication for use, design, recommended contact time, chemical composition, physical & performance properties and etc. Also, the physical and performance properties of subjective device are not significant different between the subject device and the predicate device.

The subject device is composed of tricalcium phosphate while predicate device is composed of dibasic sodium phosphate and calcium sulfate dihydrate. All of these raw materials cause blockage of dentinal tubule to achieve the intended function of device. Also tricalcium phosphate of subject device is actually a resultant chemical compound from raw materials of predicate device; dibasic sodium phosphate and calcium sulfate dihydrate in oral condition.

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Both subject device and predicate device produced with same amount of sodium fluoride contents.

The flavor and storage condition are different between subject device and predicate device which do not raise question or concerns.

IX. CONCLUSIONS

Based on a comparison of technology and Indications for use, together with in vitro performance testing, the subject device of V-varnish™ Premium is substantially equivalent to the predicate of Enamel Pro Varnish.