(76 days)
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No
The summary describes a dental cement with no mention of AI or ML capabilities.
No
Maxcem 2 is a dental cement used for the permanent attachment of dental restorations, which is a restorative rather than a therapeutic function.
No
The document describes Maxcem 2 as a resin cement intended for the cementation of dental restorations. Its function is to physically bond materials, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "paste/paste formulation" and is "packaged in dual barrel syringes with single-use automix tips," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Maxcem 2 is for the cementation of dental restorations (inlays, onlays, crowns, bridges, posts, veneers, etc.) and related dental procedures (core-buildup, pit and fissure sealant). These are all procedures performed directly on or in the patient's mouth for therapeutic or restorative purposes.
- Device Description: The description details a dental cement used for bonding materials within the mouth.
- 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 in vitro (outside the living body) to analyze biological samples. Maxcem 2 is used in vivo (within the living body) for dental restoration.
N/A
Intended Use / Indications for Use
The intended use of Maxcem 2 is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restoration to implants. Note: Adhesive application on the prep is required for veneer cementation using Maxcem 2.
Product codes
MZW, EMA
Device Description
Maxcem 2 is a self-etch, self-adhesive resin cement offered in a paste/paste formulation indicated for indirect cementation of ceramic, resin and metal restorations including veneers. This product contains 69% filler by weight and is radiopaque. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration or tooth prep.
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)
Maxcem, Nexus 3, Optibond Solo Plus 3
Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller, sans-serif font. The logo is in black and white.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
JAN 2 9 2008
Date Summary Prepared:
November 2007
Device Name:
- · Trade Name Maxcem 2
- · Common Name Dental Cement
- · Classification Name Cement, Dental, per 21 CFR § 872.3275(b)
Devices for Which Substantial Equivalence is Claimed:
- · Maxcem, Kerr Corporation
- · Nexus 3, Kerr Corporation
- · Optibond Solo Plus 3, Kerr Corporation
Device Description:
Maxcem 2 is a self-etch, self-adhesive resin cement offered in a paste/paste formulation indicated for indirect cementation of ceramic, resin and metal restorations including veneers. This product contains 69% filler by weight and is radiopaque. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration or tooth prep.
Intended Use of the Device:
The intended use of Maxcem 2 is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restoration to implants. Note: Adhesive application on the prep is required for veneer cementation using Maxcem 2.
Substantial Equivalence:
Maxcem 2 is substantially equivalent to other legally marketed devices in the United States. Maxcem 2 functions in a manner similar to Maxcem, Optibond Solo Plus 3 and Nexus 3, all currently marketed by Kerr Corporation.
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
JAN 29 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K073209
Trade/Device Name: Maxcem 2 Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: MZW, EMA Dated: November 9, 2007 Received: November 14, 2007
Dear Ms. Boswell:
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.
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Page 2 - Ms. Boswell
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 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 vours.
Sophie Y. Michael Ms.
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
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Indications for Use
510(k) Number (if known):
Device Name: Maxcem 2
Indications For Use:
Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants.
- Adhesive application on the prep is required for veneer cementation using Maxcem 2.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Susan Runse