The Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit provides immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen. For use by trained professionals.

For temporary relief from a lost filling, chipped tooth, or irritation by orthodontic wire or denture clasp or for temporary stabilization of a loosened or knocked out permanent tooth. Used by persons in remote areas such as during military field service when access to a dentist or dental equipment and facilities are not available for an extended period of time and effective treatment is necessary to prevent discomfort or delay in treatment may aggravate the injury.

Device Description

Dentist In A Box intends to assemble U.S. FDA regulatory cleared and/or exempt devices into a convenience kit for the U.S. market.

The kit components are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., not claiming or causing a new use for the component(s)).

The components are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status.

Components:
Hand-held mouth mirror
Sterile Cotton-tipped swabs
Temporary filling material
Tooth splinting material
Sterile unbuffered Saline Solution 0.9%, 5ml unit dose
Sterile Disposable gloves

AI/ML Overview

The provided text describes a 510(k) submission for a convenience kit, not a study evaluating a device's performance or acceptance criteria in the manner requested. The submission is for the "Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit".

Therefore, I cannot extract the information you requested about acceptance criteria and a study proving device performance because no such study was performed or is referenced in the provided text.

Here's why and what the document does provide:

No Clinical Study/Non-Clinical Test Summaries: The document explicitly states "Non-Clinical Test Summaries: N/A" and "Clinical Study Summary: N/A". This means no studies were conducted to assess the performance of the kit as a whole or its individual components beyond their existing regulatory status.
Substantial Equivalence: The basis for this 510(k) clearance is "substantial equivalence" to a predicate device (Cavit-W temporary crown and bridge resin K875133) for the only Class II device component in the kit, and the fact that other components are either pre-Amendments, exempt, or previously cleared devices.
Convenience Kit: The device is a "convenience kit," an assembly of already cleared or exempt devices. The regulatory approach for such kits often focuses on the components' individual clearances and the kit's intended use not introducing new questions of safety or effectiveness.

To directly answer your numbered requests based on the provided text, using "N/A" where the information is not present:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria Reported Device Performance
N/A N/A
(The submission does not present specific performance criteria or data, as it relies on substantial equivalence of its components.)
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): N/A (No test set mentioned)
- Data Provenance: N/A (No data from a test set mentioned)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: N/A
- Qualifications of Experts: N/A
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: N/A
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study Done: No.
- Effect Size: N/A
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: N/A
The sample size for the training set:
- Sample Size (Training Set): N/A
How the ground truth for the training set was established:
- Ground Truth Establishment: N/A

Acceptance Criteria	Reported Device Performance
N/A	N/A
(The submission does not present specific performance criteria or data, as it relies on substantial equivalence of its components.)

Summary

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1084

K120695 Convenience Kit - Dental Emergency Kit Plus Tooth Trauma Care Kit

510(k) Summary

Submitter:

Dr. John Banky

Dentist In A Box Pty Ltd.

44 Horace Street

Malvern 3144, Victoria, AUSTRALIA

61.3.9528.5388 Phone:

E-mail: dentabox@dentistinabox.com.au

Date Prepared: March 4, 2012

Name of Device and Classification:

Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Trade Name: Care Kit

Common Name: Dental Emergency Kit Plus Tooth Trauma Care Kit

Classification Name: Convenience Kit

Classification: Class II (According to FDA guidance, the classification of a kit is based on the highest classification of the devices that are provided in the kit. In the case of Dental Emergency Kit Plus Tooth Trauma Care Kit, the highest class device is Class II.

Product Code: TBD

There is one Class II device subject to a predicate in the Predicate Device: Convenience Kit and is it's own predicate; Cavit-W temporary crown and bridge resin K875133. It is assembled into the kit as packaged from the manufacturer.

Device Description and Predicate Device:

JUN 1 2 2002

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zofy

K120695 Convenience Kit - Dental Emergency Kit Plus Tooth Trauma Care Kit

Dentist In A Box intends to assemble U.S. FDA regulatory cleared and/or exempt devices into a convenience kit for the U.S. market.

The components are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status.

Quantity	Component	Use in the kit
1	Hand-held mouth mirror	Visualize traumatized, injured area
Pack of 2	Sterile Cotton-tipped swabs	Used to apply temporary filling material
1 x 7 gram tube	Temporary filling material	Temporary restoration to be applied to exposed tooth surfaces
1 package	Tooth splinting material	Support injured tooth molding between injured and non-injured neighboring tooth
5 ml	Sterile unbuffered Saline Solution 0.9%, 5ml unit dose	Rinse dirt from tooth as necessary and as storage medium for avulsed tooth
1 pair package	Sterile Disposable gloves	Provides a barrier against potentially infectious materials and other contaminants

		Dentist In A Box Convenience Kit Components------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	And The First of Children Comments of Children Comments ofCompany of Children Company of the property and

Intended Use/Indications for Use - 21 CFR 807.92(a)(5):

Intended Use

Indications for Use

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128695

K120695 Convenience Kit - Dental Emergency

Technological Characteristic:

The only class II device subject of comparison to a predicate in the Dental Emergency Kit Plus Tooth Trauma Care Kit is Cavit · W temporary crown and bridge resin K875133. All components in the convenience kit including the Cavit-W are assembled into the kit as packaged from the manufacturer. The device is unchanged thus technological characteristics are same.

Expiration Date

Expiration dating of the components are as follows:

Cotton-tipped swabs = 3 years

Cavit™ W Temporary filling material = 18 months

Eakin Cohesive Skin Barriers and Seals = stable, no expiration

Sterile unbuffered Saline Solution 0.9%, 5ml unit dose = 3 years

Sterile Disposable gloves = 3 years

The expiration date of the kit will be 18 months or the expiration date of the shortest dated component in the kit that have printed expiration dates on the packaging as received from the manufacturer; whichever is shorter.

Non-Clinical Test Summaries: N/A

Clinical Study Summary: N/A

Conclusion:

Based upon the information provided, The Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit is substantially equivalent to the predicate

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K120695

4874

K120695 Convenience Kit - Dental Emergency Kit Plus Tooth Trauma Care Kit

devices for the stated intended use. All components of the convenience kit have been found to be substantially equivalent through the premarket notification process or are exempt from premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing service to the nation. The eagle is positioned to the right of a circular seal that contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

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

Mr. John Banky Owner and President Dentist In A Box Pty Ltd. 44 Horace Street Malvern, Victoria AUSTRIA 3144

JUN 1 2 2012

Re: K120695

Trade/Device Name: Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit

Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: I Product Code: EMB Dated: June 7, 2012 Received: June 8, 2012

Dear Mr. Banky:

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.

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Page 2 - Mr. Banky

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 (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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours,

Wh for.

Anthony D. Watson, B.S., M.S., M.B.A. 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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K120695

510(k) Number (if known):

Device Name: Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit

Intended Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Susan Quaser

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120695

Page _ of

(Division Sign-Off) Division of Sign-Olf)
Division of Anesthesiology, General Hospital Infection Control Antistinesiology, Gene

510(k) Number:

CONFIDENTIAL

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.