I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are related to an FDA 510(k) submission for a tooth desensitizer, but they don't include details about a performance study, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. They primarily focus on regulatory aspects like classification, predicate devices, and intended use.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES	Public Health ServiceFood and Drug Administration
	Memorandum
Date:	6/8/05
From:	DMC (HFZ-401)
Subject: Premarket Notification Number(s):	K050486/A3
To:	Division Director: DE/DAGID

The attached information has been received by the 510(k) DMC on the above referenced 510(k) submission(s). Since a final decision has been rendered, this record is officially closed.

Please review the attached document and return it to the DMC, with one of the statements checked below.

Information does not change the status of the 510(k); no other action required by the DMC; please add to image file. (Prepare K-25) THIS DOES NOT APPLY TO TRANSFER OF OWNERSHIP. PLEASE BRING ANY TRANSFER OF OWNERSHIP TO POS.

Additional information requires a new 510(k); however, the information submitted is incomplete: (Noitify company to submit a new 510(k);[Prepare the K30 Letter on the LAN]

☒ No response necessary (e.g., hard copy of fax for the truthful and accuracy statement, 510(k) statement, change of address, phone number, or fax number).

510(k) Summary revision as per my request
CLIA CATEGORIZATION refers to laboratory test system devices reviewed by the Division of Clinical Laboratory Devices (HFZ-440

Information requires a CLIA CATEGORIZATION; the complexity may remain the same as the original 510(k) or may change as a result of the additional information (Prepare a CAT letter)

Additional information requires a CLIA CATEGORIZATION; however, the information submitted is incomplete; (call or fax firm)

No response necessary

This information should be returned to the DMC within 10 working days from the date of this memorandum.

Reviewed by:	AJS8
Date	6/13/05

DMC

6/13

Draft #2: 9/8/99

Draft #3: 1/3/00

Draft #4: 3/7/03

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510(k) SUMMARY 8.

8.1 Submitter's Name and Contact Information

Submitter Company:	Sunstar Butler
Address:	4635 W. Foster Ave.
City, State, Zip	Chicago, IL 60630
Contact Person:	Name: Richard O. WoodPhone/Fax: (312) 807-4364(312) 827-8189 (Fax)Email: rowood@bellboyd.com
Date Prepared:	Date: June 6, 2005 (Amendment)

8.2 Name of Device and Name/Address of Applicant

Protect™ Tooth Desensitizer
Sunstar Butler
4635 W. Foster Ave.
Chicago, IL 60630
8.3 Name and Address of Manufacturer
Ivoclar Vivadent AG
Bendererstrasse 2
FL-9494 Schaan

8.4 Common or Usual Name

Tooth desensitizer

Liechtenstein

8.5 Classification Name

Varnish, cavity

8.6 Predicate Device

Protect is substantially equivalent to Vivasens (K030922), manufactured by Ivoclar Vivadent, Inc. and Orajel Advanced Tooth Desensitizer (K041680).

8.7 Intended Use

Protect™ Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities.

SKO9

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the body and head. The logo is black and white.

JUN 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sunstar Butler C/O Mr. Richard O. Wood Bell, Boyd & Loyd, LLC 70 West Madison Street, Suite 3300 Chicago, Illinois 60602

Re: K050486

Trade/Device Name: Protect™ Tooth Desensitizer Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 29, 2005 Received: May 2, 2005

Dear Mr. Wood:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales been 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 Interstate commerce pror to rive, as, reclassified in accordance with the provisions of Amendinents, or to de roos and Cosmetic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, und Ocoment , tweefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rion - tisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (occase of the major regulations affecting (FMA), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the evas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Wood

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisod that 1 DTC issualites on that your device complies with other requirements mean that it DAT has made a dotes and regulations administered by other Federal agencies. 01 the Act of ally I oderal barates are quirements, including, but not limited to: registration You must comply with an the Fisce Jrg (21 CFR Part 801); good manufacturing practice and listing (21 CF K Pat 607), laoelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality is a control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This felter will anon you to began finding of substantial equivalence of your device to a premarket notified.com - The Fire results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at no to: Joiance at (240) 276-0115. Also, please note the regulation please contact the Other or Ochipman premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general mirering, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janice Y. Michio md.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K050486

Device Name: Protect™ Tooth Desensitizer

INDICATIONS FOR USE: 1.

Protect™ Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities. -

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

siology, General Hospital,

510(k) Number: K030486

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.