(49 days)
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No
The 510(k) summary describes a dental cement with chemical and physical properties, not software or algorithms. There is no mention of AI, ML, image processing, or data analysis.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a cement used for dental restoration, which is a supportive rather than a therapeutic function.
No
Explanation: The device is a dental cement intended for bonding restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "self-etch adhesive resin cement offered in a paste/paste formulation," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cementation of dental restorations (inlays, onlays, crowns, bridges, and posts). This is a procedure performed on the patient's teeth, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a dental cement used for bonding restorations. It doesn't mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological samples.
- Reference to diagnostic markers or tests.
- Discussion of sensitivity, specificity, or other performance metrics relevant to diagnostic accuracy.
- Information about sample preparation or analysis procedures.
The device is clearly a dental material used in a restorative procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of MaxCem is for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.
MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.
Product codes
EMA, KLE
Device Description
The device is a self-etch adhesive resin cement offered in a paste/paste formulation indicated for the cementation of indirect ceramic, resin and metal restorations. Due to its self-etching and adhering properties, MaxCem does not require the use of an etchant, primer or adhesive. This product contains 68% filler by weight with an average filler particle size of 4 microns in the base formulation, is radiopaque and releases fluoride. The dual-cure material is packaged in automix dual barrel syringes which allow the user to deliver the desired volume of cement directly into the restoration or tooth cavity.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/0 description: The image shows a document with the date JUL 21 2004 on the left side. On the right side, the text "K041474" is at the top, followed by the logo "sds" and the text "SYBRON DENTAL SPECIALTIES". The bottom of the image contains the text "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
Date Summary Prepared: May 2004
Device Name:
- Trade Name MaxCem .
- Common Name Dental Cement .
- Classification Name Cement, Dental, per 21 CFR § 872.3275 .
Devices for Which Substantial Equivalence is Claimed:
- 3M ESPE AG Dental Products, UniCem .
Device Description:
The device is a self-etch adhesive resin cement offered in a paste/paste formulation indicated for the cementation of indirect ceramic, resin and metal restorations. Due to its self-etching and adhering properties, MaxCem does not require the use of an etchant, primer or adhesive. This product contains 68% filler by weight with an average filler particle size of 4 microns in the base formulation, is radiopaque and releases fluoride. The dual-cure material is packaged in automix dual barrel syringes which allow the user to deliver the desired volume of cement directly into the restoration or tooth cavity.
Intended Use of the Device:
The intended use of MaxCem is for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.
Substantial Equivalence:
MaxCem is substantially equivalent to other legally marketed devices in the United States. MaxCem functions in a manner similar to and is intended for the same use as UniCem that is currently marketed by 3M ESPE AG Dental Products.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2004
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K041474
Trade/Device Name: MaxCem Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and KLE Dated: May 28, 2004 Received: June 02, 2004
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your section 510(x) premanter from the material of the indications for referenced above and have decimined the ace devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicate devices than a use stated in the enclosure) to regally manations of the Medical Devices that the end Cormation prior to May 26, 1970, the chaomistic date 6- in over of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the time (PMA). You have been reclassified in accordance with the proval application (PMA). You may.
Act (Act) that do not require approval of a premarket approval application (PMA). The conserv Act (Act) that do not require approval or a provisions of the Act . The general therefore, market the device, subject to the general vor annual registration, listing of devices, good
controls provisions of the Act include requirements for annual registra controls provisions of the Netware requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Feacher in the Federal Register
2
Page 2 - Ms. Colleen Boswell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised mater 1977 viation that your device complies with other requirements of the Act or that I Dri has made a acternilations administered by other Federal agencies. You must comply with all 1 coclar statutes and 10 garanting, but not limited to: registration and listing (21 CFR Part 807); an the Ave s requirements) ; good manufacturing practice requirements as set forth in the quality iabeling (21 CFR Part 800); 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) I ms lotter with are your your e FDA finding of substantial equivalence of your device to a legally premaince notification - every 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 If you desire specific at (301) 594-4613. Additionally, for questions on the promotion contact are Crive of your device, please contact the Office of Compliance at (301) 594-4639. Also, alle we regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known):
Device Name: MaxCem
Indications For Use:
MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.
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)
Susan Rumsey
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
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