(113 days)
Not Found
No
The device description and intended use are for a dental sealant and etching gel, with no mention of AI or ML capabilities. The "Not Found" entries for AI/ML mentions and training/test sets further support this.
No
The device is described as a sealant for dental surfaces, which is a preventive measure rather than a treatment for a disease or condition. Therefore, it is not a therapeutic device.
No
The device is a sealant used for preventive dental care (sealing pits, fissures, and damaged enamel surfaces), not for diagnosing medical conditions.
No
The device description clearly states the device consists of physical components: a light curing resin-based sealant, an ethanol solution, and an HCI-Etching-Gel. These are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "light curing resin-based sealant (Infiltrant)" and an "HCI-Etching-Gel" used for "sealing the enamel pits and fissures of teeth" and "etching of enamel." These are procedures performed directly on the tooth structure within the mouth.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The device is applied directly to the patient's teeth.
Therefore, this device falls under the category of a dental device used for direct treatment and not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Sealant (Infiltrant) is indicated for:
- Sealing of Pit and Fissures .
- Sealing/facing of damaged enamel surfaces .
- . Covering of caries predilection sites during orthodontic treatment
- Sealing of secondary teeth .
- Sealing of deciduous teeth .
The HCI Etching Gel is indicated for etching of enamel.
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
The purposed Infiltration Kit consists of two components, a light curing 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 HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel pits and fissures of 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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Infiltration Kit has been shown to be safe and effective for its intended use.
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.
K992326, K021842, K062344, K891536
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
510(k) Summary
| Trade Name: | Infiltration Kit |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 23 Frank Mossberg Drive | |
| Attleboro, MA 02703 | |
| Registration # not yet assigned | |
| Owner/Operator No. 9005969 | |
| Device Generic Name: | Infiltration Kit |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. |
Product Description:
The purposed Infiltration Kit consists of two components, a light curing 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 HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.
Product Indications for Use:
The Sealant (Infiltrant) is indicated for:
- Sealing of Pit and Fissures .
- Sealing/facing of damaged enamel surfaces .
- . Covering of caries predilection sites during orthodontic treatment
- Sealing of secondary teeth .
- Sealing of deciduous teeth .
The HCI Etching Gel is indicated for etching of enamel.
Predicate Devices:
The Infiltration Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:
| Product Name | Predicates |
|---|---|
| 3M Clinpro Sealant | K992326 (3M Company USA) |
| Admira Seal | K021842 (VOCO, GmbH) |
| Grandio Seal | K062344 (VOCO, GmbH) |
HCI-Etching-Gel:
| Product Name | Predicates |
|---|---|
| Enamel Microabrasion Compound | K891536 (Premier Dental Products USA, Co.) |
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
1
Conclusion:
・
.
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Infiltration Kit has been shown to be safe and effective for its intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2008
DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device, Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K081493
Trade/Device Name: Infiltration Kit Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: September 7, 2008 Received: September 11, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a Premium results to bredicate device 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Monifacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ques
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of of
510(k) Number (if known): _ K081439
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 t
- Covering of caries predilection sites during orthodontic treatment .
- Sealing of secondary teeth .
- Sealing of deciduous teeth .
The HCI Etching Gel is indicated for etching of enamel.
Prescription Use X (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)
MSR
(Division Sign Off)
OR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091493