(63 days)
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No
The summary describes a dental impression material, which is a physical substance and does not involve software or data processing, let alone AI/ML.
No
The device is an impression material used for diagnostic or preparatory purposes, not for treating a disease or condition.
No
The device, P2 Polyether Impression material, is used for taking impressions for various dental restorations (inlay, onlay, crown & bridge, functional, and implant impressions). It is a material used in the process of creating a physical record for fabrication, not for diagnosing a condition or disease.
No
The intended use describes an "Impression material," which is a physical substance used in dentistry, indicating a hardware component.
Based on the provided information, the P2 Polyether Impression material is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material being used for creating impressions of teeth and surrounding structures for dental restorations and implants. This is a physical process of capturing a mold, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Purpose: IVDs are used to diagnose diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The P2 Polyether Impression material does not perform any such diagnostic function.
- No Mention of Biological Samples: IVDs typically involve testing biological samples (blood, urine, tissue, etc.). The description of the impression material does not mention the use of any biological samples.
Therefore, the P2 Polyether Impression material is a dental material used for creating physical impressions, not a diagnostic device.
N/A
Intended Use / Indications for Use
P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.
Product codes
ELW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
APR - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl V. Zimmerman Manager, Ouality Operations & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K030318
Trade/Device Name: P2 Polyether Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: January 29, 2003 Received: January 30, 2003
Dear Ms. Zimmerman:
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, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Cheryl V. 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. You must comply 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 requirements 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 vours.
Susan Gunner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K030318 510(k) Number (if Known):
Device Name: P2 Polyether Impression Material
Indications For Use:
P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Kein Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: