(60 days)
Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
Flexitime Xtreme is a polyvinylsiloxane silicone impression material.
This document is a 510(k) clearance letter for a dental impression material, Flexitime Xtreme. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/machine learning. Therefore, I cannot extract the requested information.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Ms. Cheryl V. Zimmerman Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K042878
Trade/Device Name: Flexitime Xtreme Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: October 14, 2004 Received: October 25, 2004
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your because mined the device is substantially equivalent (for the referenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device nicesure ecomments, or to devices that have been reclassified in accordance with the provisions of / Includinents, of to do Tosmetic Act (Act) that do not require approval of a premarket the readeral I beath I beagh therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls 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 If your dovice is classince to such additional controls. Existing major regulations affecting (1 vir ), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be rounder announcements concerning your device in the Ecderal Register.
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Page 2 - Ms. Zimmerman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or mo rot of any I 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 and insting (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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) 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 regulation (21 CFR Part 801), r lyse contact the Office of Compliance at (240) 276-0115. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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): K042878
Device Name: Flexitime Xtreme
Indications for Use: Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
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)
Supd Russd
(Division Sign-Off)
( - Cloin Olgh-Oll)
Division of Anesthesiology, General Hospital, Infection of Anesthesiology, Gene
510(k) Number: Y 042878
Page 1 of
§ 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).