(77 days)
Not Found
Not Found
No
The 510(k) summary describes a dental resin and does not mention any AI or ML components.
No.
The device is described as a resin used for making dentures, which is a dental prosthetic, not a therapeutic device.
No
This device is described as a dual technique resin used for creating dentures and dental repairs, which is a therapeutic rather than a diagnostic function.
No
The device description clearly indicates it is a resin material used for dental applications, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the creation and repair of dentures, which are medical devices used in the body, not for testing samples from the body.
- Device Description: The description confirms it's a resin for creating dentures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing conditions, or providing information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. This device is a material used to fabricate a prosthetic device.
N/A
Intended Use / Indications for Use
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique. Cold curing: -upper and lower full dentures (pour technique) -completion of partial dentures -repairs Heat Cure: - upper and lower full dentures (presspack technique)
Product codes
EBI
Device Description
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human figures or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Mr. Raphael Judkins Ouality Systems Administrator J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
Re : K990056 JelDent™ Multicryl Trade Name: Requlatory Class: II Product Code: EBI Dated: December 31, 1998 Received: January 7, 1999
Dear Mr. Judkins:
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 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). You may, therefore, market the device, subject to the qeneral 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. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Judkins
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Palitrea Cucurbitafloe
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Jelenko Dental Health Products. The logo consists of the word "JELENKO" in large, bold, black letters. Below the word "JELENKO" are the words "DENTAL HEALTH PRODUCTS" and "ISO 9001 REGISTERED" in smaller, black letters.
BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA http://www.jelenko.com
(800) 431-1785 PHONE: (914) 273-8600 FAX: (914) 273-9379
INDICATIONS FOR USE
Page 1 of 2
510(k) Number: K990056
Device Name:
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique.
Cold curing: -upper and lower full dentures (pour technique) -completion of partial dentures -repairs
Heat Cure: - upper and lower full dentures (presspack technique)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CHRD, OFFICE OF DEVICE EVALUATION (OED)
| Susan Plummer | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K990056 |
| Prescription use ✓ (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| ----------------------------------------- | ---- | ----------------------------- |