(23 days)
Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.
Crown Delta Hydrophilic Impression Material is a hydrophilic vinyl polysiloxane impression material.
The provided document is a 510(k) premarket notification letter from the FDA regarding the "Crown Delta Hydrophilic Impression Material." This document does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:
- Trade/Device Name: Crown Delta Hydrophilic Impression Material
- Regulation Number/Name: 872.3660, Impression Material
- Regulatory Class: II
- Product Code: ELW
- Indications for Use: Making impressions of teeth and gums for models, applied via a dual syringe system into a tray or directly onto teeth. The hydrophilic enhancement aims for more accurate impressions in adverse conditions (e.g., blood or saliva).
To answer your specific questions regarding acceptance criteria and a study, this document does not provide the required details. Such information would typically be found in the manufacturer's 510(k) submission itself, which is a much more extensive technical document, or in a separate clinical study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Mr. Mark P. Konopka Manager of Regulatory Affairs Crown Delta Corporation 1550 Front Street Yorktown Heights, New York 10598
Re: K041028
Trade/Device Name: Crown Delta Hydrophilic Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 20, 2004 Received: April 21, 2004
Dear Mr. Konopka:
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, I DA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Konopka
Please be advised that FDA's issuance of a substantial equivalence determination does not I toase of act race a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rever any 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 uncilling (2) roquirents as as roonic 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 mo letter notification. The FDA finding of substantial equivalence of your device to a premaired predicated. - I a 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), n 130 contact the Office of Compliance 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 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
Sincerely yours,
Clue
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):_KO41078
Device Name: Crown Delta Hydrophilic Impression Material
Indications for Use:
Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.
Prescription Use / AND/OR (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)
Supe
sthesiology, General Hospital,
510(k) Number: K041027
Page 1 of 1
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).