(97 days)
No
The device is a kit of pre-existing, cleared or exempt dental supplies for temporary relief, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is described as providing "immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen" and for "temporary stabilization of a loosened or knocked out permanent tooth," which indicates a therapeutic purpose.
No
Explanation: The device description states its purpose is to provide "immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen." It focuses on treatment and relief rather than diagnosing conditions.
No
The device description explicitly lists physical components such as a hand-held mouth mirror, cotton-tipped swabs, temporary filling material, tooth splinting material, saline solution, and disposable gloves. This indicates it is a kit containing physical medical devices, not a software-only device.
Based on the provided information, the Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for providing immediate, temporary relief from common dental problems, accidents, and trauma. This involves direct application and manipulation within the mouth, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The components are physical tools and materials used for temporary dental repairs and stabilization (mirror, swabs, filling material, splinting material, saline, gloves). These are not reagents, instruments, or systems intended for use in the in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any processes involving the analysis of biological samples (blood, saliva, tissue, etc.) outside of the body.
- Anatomical Site: The anatomical site is the tooth and mouth, which are the areas where the physical interventions are performed.
- Predicate Device: The listed predicate device (K875133 Cavit-W temporary crown and bridge resin) is a temporary dental filling material, which is consistent with a non-IVD dental device.
In summary, the Dentist In A Box kit is a collection of tools and materials for direct, temporary dental care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
EMB
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.
Kit components:
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals / remote areas such as during military field service
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 Test Summaries: N/A
Clinical Study Summary: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cavit-W temporary crown and bridge resin K875133
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 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.
| 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 of
Company of Children Company of the property and | |
Intended Use/Indications for Use - 21 CFR 807.92(a)(5):
Intended Use
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.
Indications for Use
2
128695
K120695 Convenience Kit - Dental Emergency
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.
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
3
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.
4
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.
5
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
6
510(k) Number (if known):
Device Name: Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit
Intended Use:
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.
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