(79 days)
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No
The summary describes a dental cement system with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is a dental cement system used for indirect cementation of dental prosthetics. It does not state any therapeutic function such as treating or preventing disease.
No
The device is a dental cement system used for the adhesion of dental restorations, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical dental cement system consisting of a primer and a two-part cement supplied in bottles and syringes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts." This describes a dental procedure involving the placement and bonding of restorative materials within the mouth.
- Device Description: The description details a "dental cement system" used for bonding dental restorations.
- 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 screening.
IVD devices are used to perform tests on samples from the body, while this device is used within the body for a restorative dental procedure.
N/A
Intended Use / Indications for Use
SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light. The intended use of SEcure is for indirect cementation of porcelain, ceramic, resin and metal-based inlays, onlays, crowns, bridges, veneers and posts.
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metal-based inlays, onlays, crowns, bridges, veneers and posts.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510(k) SUMMARY
| Submitter: | Parkell, Inc.
300 Executive Drive
Edgewood, NY 11717
TEL: 631-249-1134
FAX: 631-249-1242 | MAR 19 2008 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Daniel R. Schechter, Esq.
General Counsel
Parkell
300 Executive Drive
Edgewood, NY 11717 | |
| Submission Date: | 28 December 2007 | |
| Trade Name: | SEcure | |
| Common Name: | Dental Cement | |
| Classification Name: | Dental Cement | |
| Equivalence: | TOTALBOND, MAXCEM, UNICEM | |
| Description/Intended Use: | SEcure is a dual-cure, self-etching, adhesive dental
cement system consisting of a self-etching primer and a
two-part dental cement. The self-etching primer is
supplied in a single bottle, while the dental cement is
supplied in a double-barrel auto-mix syringe. The
cement system does not require acid etching of tooth
surfaces, and can be cured with any available curing
light. The intended use of SEcure is for indirect | |
posts.
:
cementation of porcelain, ceramic, resin and metalbased inlays, onlays, crowns, bridges, veneers and
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2008
Mr Daniel R. Schechter, Esq. Parkell, Incorporated 300 Executive Drive Edgewood, New York 11717
Re: K073698
Trade/Device Name: SEcure Adhesive Dental Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 28, 2007 Received: December 31, 2007
Dear Mr. Schechter:
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.
2
Page 2 - Mr. Schechter
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 (OS) 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 legally marketed predicate 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Runner
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
3
Indications for Use
510(k) Number (if known):
Ko73698
Device Name: SEcure Adhesive Dental Cement
Indications for Use:
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunner
Division Sign-Off) ivision of Anesthesiology, General Hospital ntection Control, Dental Devices
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10(k) Number. K73658