(78 days)
K/DEN: Not Found
Not Found
No
The summary describes a dental resin cement and does not mention any AI or ML capabilities.
No
The device is a dental resin cement used for permanent bonding of restorations to tooth structure, which is a restorative material rather than a therapeutic device. It does not actively treat a disease or condition, but rather serves to hold a restoration in place.
No
The device is a dental resin cement used for permanent cementation of dental prosthetics to tooth structure, which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states it is a "dental resin cement," which 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 to permanently cement dental restorations (crowns, inlays, etc.) to tooth structure. This is a direct application within the body (or on a part of the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a dental resin cement for direct application.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pulpdent VLC Resin Coment is a fluoride releasing, visible light-cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, bridges, veneers, and periodontal splints to tooth structure.
Product codes
76 EMA
Device Description
PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Pulpdent Post Cement, Pulpdent ResiLute, Kuraray / J. Morita Panavia F, ESPE Compolute Aplicap, lvoclar / Vivadent Variolink II
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.
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1
Ko40236
APR 2 0 2004
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: 617-926-6262 Fax: ken@pulpdent.com
DEVICE: Trade Name: PULPDENT VLC RESIN CEMENT Classification Name: Dental Cement FDA Product Code: 76 EMA, 21 CFR Part 872.3275
PREDICATE DEVICE:
Pulpdent Post Cement Pulpdent ResiLute Kuraray / J. Morita Panavia F ESPE Compolute Aplicap lvoclar / Vivadent Variolink II
DESCRIPTION AND INTENDED USE:
PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
SAFETY AND EFFECTIVENESS:
PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3275.
According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.
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. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K040236
Trade/Device Name: Pulpdent VLC Resin Cement Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 28, 2004 Received: February 2, 2004
Dear Mr. Berk:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother of a now and have determined the device is substantially equivalent (for the icitications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to active 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 upprovisions of the Act. The general controls provisions of the Act include controls providents of the sixtation, 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 If your device to such additional controls. Existing major regulations affecting (1 Mrs), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the Federal Register.
2
Page 2 - Mr Berk
Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisou mat 1 DTC Isbance or abat your device complies with other requirements mean that FDA has made a detes and regulations administered by other Federal agencies. of the Act of ally I ederal states and regirements, including, but not limited to: registration 1 ou must comply with an alle Hotel Stag (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), abality systems (QS) regulation (21 CFR Part 820); and if requirenchts as set form in the quarty ajon 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) This letter will anow yourse overnment of substantial equivalence of your device to a premaired 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), If you desire speomle at 100 to: Join we at (301) 594-4613. 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 may obtain other generational 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,
Ken Mulvey
for 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
K040236 AND 200
510 (k) Number (if known)
PULPDENT VLC RESIN CEMENT Device Name
Indications for Use:
Pulpdent VLC Resin Coment is a fluoride releasing, visible light-cure dental resin rement that contains no Bisphenol A. It is used to permanently cement ceramic coment that contains no crowns, inlays, onlays, bridges, bridges, veneers, and periodontal splints to tooth structure.
Prescription Use __ (Part 21 CFR 801 Subpart D) ா
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) (Division Sign-C (Division Sign-Off)
Division of Anesthesiology - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Division of Anesthoolorsis Devices 444 510(k) Number: Page 1 of 1