(30 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of the impression material, with no mention of AI or ML.
No
The device is an impression material used to create molds for dental restorations, not for treating a disease or condition.
No
The device is an impression material used to create molds of teeth for restorations, which is a manufacturing/restoration purpose, not a diagnostic one.
No
The device description explicitly states it is a polyether tray impression material, which is a physical material, not software. It also mentions being used with a mixing, dosing, and dispensing device (Garant™), further indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating impressions of teeth for dental restorations. This is a physical process for creating a mold, not a test performed on a sample of human origin to provide information about a physiological or pathological state.
- Device Description: The device is an impression material, a substance used to capture the shape of teeth. This is a material used in a physical procedure, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are typically used to test samples like blood, urine, tissue, etc., to diagnose diseases, monitor health conditions, or screen for specific substances. This device's function is purely mechanical – creating a physical impression.
N/A
Intended Use / Indications for Use
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Product codes
ELW
Device Description
PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth
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)
To provide evidence for safety biocompatibility testing was carried out. The results show that PECD-01 and PECD Quick-01 are safe devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 2 6 2008
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| Date: | February 18, 2008 |
| Name of Devices | |
| Proprietary Name: | PECD-01 |
| PECD Quick-01 | |
| Classification Name: | Impression material |
| Common Name: | Dental impression material |
| Predicate Devices | |
| Impregum™ Penta™ M Monosoft by 3M ESPE | K994192 |
Poly Q Penta M by 3M ESPE. ..........................................................................................................................K032001 Ramitec Penta by 3M ESPE .....................................................................................................................................................
1
Description for the Premarket Notification
PECD-01 and PECD Quick-01 are classified as Impression material (21 C.F.R. § 872,3660) because the products are devices intended to reproduce the structure of a patient's teeth.
3M ESPE is submitting this 510(k) premarket notification for modifications to its polyether based impression material Impregurn Penta M Monosoft. The modification is in chemical composition but, however, the fundamental character of the chemistry of Impregum Penta M Monosoft was not changed. Like Impregum Penta M Monosoft, PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. While Impregum Penta M Monosoft is intended to be used in 3M ESPE's automatic mixing, dosing and dispensing device Pentamix, PECD-01 and PECD Quick-01 are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.
PECD-01 and PECD Quick-01 have the same fundamental scientific technology and the same intended use as Impregum Penta M Monosoft.
To provide evidence for safety biocompatibility testing was carried out. The results show that PECD-01 and PECD Quick-01 are safe devices.
The comparison for chemistry, performance data and indications for use shows that PECD-01 and PECD Quick-01 are substantially equivalent to the predicate devices.
In summary, it can be concluded that safety and effectiveness requirements for PFCD-01 and PECD Quick-01 are completely met.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld. Bavaria, GERMANY D-82229
MAR 2 6 2008
Re: K080514
Trade/Device Name: PECD-01, PECD Quick-01 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 18, 2008 Received: February 25, 2008
Dear Dr. Soegiarto:
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.
3
Page 2 - Dr. Soegiarto
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 your 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 (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/industry/support/index.html.
Sincerely yours,
Smith K. Michie Davis
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
4
K 080514
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
PECD-01, PECD Quick-01
Impressions for inlay, onlay, crown, and bridge
restorations
Functional impressions
Fixation impressions
Implant impressions
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albut Betz aos for Dr. Runner
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K080514