(74 days)
Not Found
No
The device description and intended use are focused on a dental sealant and etching gel, with no mention of AI or ML capabilities. The performance studies are limited to material properties like viscosity and depth of cure.
Yes
The device is a medical device (Sealant and Etching Gel) intended for sealing, coating, and etching tooth surfaces to prevent caries and treat lesions, which falls under the definition of a therapeutic device due to its direct medical benefit.
No
The device is a sealant and an etchant used to prevent caries and treat enamel surfaces, not to diagnose medical conditions.
No
The device description clearly states it consists of physical components: a light curing methacrylate resin-based Sealant (Infiltrant), a 99.5% ethanol solution, and an HCl-Etching-Gel. These are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to treating or protecting tooth surfaces within the mouth. This includes sealing pits and fissures, sealing damaged enamel/dentin, covering caries predilection sites, and acting as a protective coating. These are all in vivo applications, meaning they are performed on a living organism (the patient).
- Device Description: The device components (sealant, ethanol solution, etching gel) and their described functions (etching enamel, drying, sealing) are consistent with dental materials used directly on teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used outside the body to analyze biological samples. This device is clearly intended for direct application inside the mouth on the teeth.
N/A
Intended Use / Indications for Use
-
- The Sealant (Infiltrant) is indicated for:
- -Sealing of pits and fissures
- -Sealing/facing of damaged enamel surfaces
- -Covering of caries predilection sites during orthodontic treatment
- -Sealing of secondary teeth
- -Sealing of deciduous teeth
- Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces)
-
- HCI-Etching-Gel is indicated for:
- -Etching of enamel
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
The DMG USA Infiltration Kit consists of two components, a light curing methacrylate resin-based Sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the Sealant application and as second component an HCl-Etching-Gel. As preliminary step the HCl-Etching-Gel is used for etching of enamel. The Sealant (Infiltrant) is a low viscosity light-curing dental resin, which is a protective coating for tooth surfaces predisposed to caries or on early non-cavitated Jesions. Other uses include sealing of pits and fissures, damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces (pits and fissures, damaged enamel surfaces, exposed dentin surfaces), deciduous teeth, secondary teeth
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)
Substantial equivalence testing was limited to viscosity and depth of cure for the two materials (new and predicate). The new and predicate materials are identical in terms of depth of cure; there is less than a 5% difference in viscosity between the DMG USA device and the predicate 3M ESPE device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
Section 5-510(k) Summary
| Trade Name: | Infiltration Kit |
|---|---|
| Date Prepared: | MAR 2 6 2010 |
| March 12, 2010 | |
| Sponsor: | DMG USA, Inc. |
| 23 Frank Mossberg Drive | |
| Attleboro, MA 02703 | |
| David Sklarski | |
| 508-226-5660 | |
| Registration # not yet assigned | |
| Owner/Operator No. 9005969 | |
| Device Common/Usual Name: | Infiltration Kit |
| Classification/Regulation: | Sealant, Pit & Fissure, and Conditioner (21 CFR 872.3765; Class II) |
| Predicate Devices: | Infiltration Kit; K081439 (DMG USA, Inc.) |
| SPK Sealant; K091632 (3M ESPE) |
Product Description:
The DMG USA Infiltration Kit consists of two components, a light curing methacrylate resin-based Sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the Sealant application and as second component an HCl-Etching-Gel. As preliminary step the HCl-Etching-Gel is used for etching of enamel. The Sealant (Infiltrant) is a low viscosity light-curing dental resin, which is a protective coating for tooth surfaces predisposed to caries or on early non-cavitated Jesions. Other uses include sealing of pits and fissures, damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries.
Product Indications for Use:
- The Sealant (Infiltrant) is indicated for:
- Sealing of Pits and Fissures -
- Sealing/facing of damaged enamel surfaces -
- Covering of caries predilection sites during orthodontic treatment -
- Sealing of secondary teeth -
- -Sealing of deciduous teeth
- Sealing of pits and fissures, damaged enamel surfaces of teeth to prevent caries -
- Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions -HCI-Etching-Gel is indicated for:
- Etching of enamel .
Substantial Equivalence
Substantial Equivalence for the DMG Infiltration Kit is based upon physical comparison to the predicate device: the Infiltration Kit described in this submission is identical to that cleared in K081493. This submission is for a labeling change to expand the indications for use statement for the Infiltration Kit cleared in K081439 to include two specific uses for the material: Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries and Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces).
Technological Characteristics
The Infiltration Kit described in this submission is identical to the Infiltration Kit cleared in K081493. The chemical compositions of the Infiltration Kit materials are also equivalent to those of the 3M ESPE SPK Sealant, which was cleared in K091632 for the same indications for use proposed in this submission. Because the DMG USA Infiltration Kit and 3M ESPE SPK Sealant materials are so close in chemical
1
composition, the substantial equivalence testing provided in this submission is limited to viscosity and depth of cure for the two materials. The new and predicate materials are identical in terms of depth of cure; there is less than a 5% difference in viscosity between the DMG USA device and the predicate 3M ESPE device.
Conclusion:
Based on the indications for use, technological characteristics, and in-vitro test data contained in this submission, the Infiltration Kit has been shown to be safe and effective for its intended use.
2
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 stylized graphic of an abstract human figure with three lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Pamela Papineau, Regulatory Affairs Consultant DMG USA, Incorporated 23 Frank Mossberg Drive Attleboro, Massuchusetts 02703
Re: K100062
MAR 2 6 2010
Trade/Device Name: Infiltration Kit Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Codes: EBC Dated: January 8, 2010 Received: January 15, 2010
Dear Ms. Papineau:
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.\
3
Page 2 - Ms. Papineau
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 eventsunndarthe 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.
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
4
DMG USA, Inc. Abbreviated 510{k} Premarket Notification
29 December 2009 Infiltration Kit
of
Page
510(k) Number (if known): K100062
Device Name: Infiltration Kit
Product Indications for Use:
-
- The Sealant (Infiltrant) is indicated for:
- -Sealing of pits and fissures
- -Sealing/facing of damaged enamel surfaces
- -Covering of caries predilection sites during orthodontic treatment
- -Sealing of secondary teeth
- -Sealing of deciduous teeth
- Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces)
-
- HCI-Etching-Gel is indicated for:
- -Etching of enamel
Prescription Use X OR (Per 21 CFR 801 Subpart D)
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr.K.P.Muly
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K100062