(98 days)
Not Found
Not Found
No
The description focuses on the chemical composition and intended use of a dental adhesive cement, with no mention of AI or ML technologies.
No
The device is described as an adhesive cement for bonding dental restorations and repairing fractured dental porcelains, which serves a restorative rather than a therapeutic function.
No
The device description indicates it is an adhesive cement used for bonding and repairs, not for diagnosing medical conditions.
No
The device description clearly describes a physical adhesive cement and associated primers, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "curing adhesive cement" used for bonding dental restorations (inlays, onlays, crowns, bridges, veneers) to teeth and for repairing fractured dental porcelains.
- No Specimen Analysis: The device does not analyze any biological specimens from the human body to diagnose, monitor, or treat a medical condition. Its function is purely mechanical/adhesive within the oral cavity.
Therefore, this device falls under the category of a dental material or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Parkell's TOTALBOND is a dual-curing adhesive cement intended for use as a luting material for bonding inlays, onlays, crowns, and bridges to properly prepared teeth. It is also indicated for use as an agent for affecting repairs of tooth-colored veneers bonded to dental alloys, either non-precious or precious. For the latter instance, the supplied kit contains a noble metal-Priming material which significantly increases the bond strength of the repair. The kit also contains a porcelain-primer that is recommended for use in repairing fractured dental porcelains. It mediates an adhesive bond between the porcelain substrate and an overlying composite resin.
A BURL. CURING ADHESIVE CEEMENT INTENDED FOR USE AS A LUTING MATERIAL FOR BONDING INLAYS, ONLAYS, CROWNS, BRIDGES, LAMINATE VENEERS ETC. TO POSTERLY PERFARED TEETH. ALSO INDICATED AS AN AGENT FOR AFFECTING REPAIRS OF TOOTH . COLORED VENEED VENEERS BUNDED TO ATT ECTING READING FOR FREGOUS OR PRECIOUS . FOR THE LATTER, THE KIT CONTAINS A NOBLE METAL PRIMING MATERIAL WHICH SIGNIFICANTLY INCREASES THE BONS STRENGTH OF THE REPAIR. THE KIT ALSO CONTAINS A PORCELAIN PRIMER OF THE IS RECORITIENDED FOR WE IN REBAIRING FRACTURED DENTAL PORCECAINS. IT MEDIATES AN ADHESINE BOND BETWEEN THE PORCECAIN SUBSCRIPTE AND AN OVERLIANG COMPOSITE PESIN.
Product codes
EMA
Device Description
Parkell's TOTALBOND is a dual-curing adhesive cement
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, dental alloys, fractured dental porcelains
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAY 1 7 113
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K99038
:
510(k) SUMMARY
| Submitter: | Parkell Products Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 516-249-1134
FAX: 516-249-1242 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735 |
| Submission Date: | February 3, 1999 |
| Trade Name: | TOTALBOND |
| Common Name: | Adhesive Resin Cement |
| Classification Name: | Cement, Dental (§872.3275) |
| Equivalence: | |
| Description/Intended Use: | Parkell's TOTALBOND is a dual-curing adhesive cement
intended for use as a luting material for bonding inlays, onlays,
crowns, and bridges to properly prepared teeth. It is also indicat-
ed for use as an agent for affecting repairs of tooth-colored
veneers bonded to dental alloys, either non-precious or precious.
For the latter instance, the supplied kit contains a noble metal-
Priming material which significantly increases the bond strength
of the repair. The kit also contains a porcelain-primer that is
recommended for use in repairing fractured dental porcelains. It
mediates an adhesive bond between the porcelain substrate and an
overlying composite resin. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735
Re : K990381 Trade Name: TOTALBOND Regulatory Class: II Product Code: EMA Dated: April 30, 1999 Received: May 7, 1999
Dear Dr. Gendusa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Paqe 2 - Dr. Gendusa
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): )