(78 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of impression materials, with no mention of AI or ML technologies.
No.
The device is indicated for taking impressions of anatomical structures, which is a diagnostic or procedural step, not a therapeutic intervention to treat or prevent a disease or condition.
No
The device is an impression material used to create molds of dental structures, not to diagnose a medical condition. Its intended use is for impressions for temporary restorations, preliminary impressions, opposing dentitions, and orthodontic models.
No
The device description clearly states it is an "impression material" composed of "base paste and catalyst," which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for taking impressions for temporary restorations, preliminary impressions, opposing dentitions, and orthodontic models. This is a physical process performed directly on the patient's mouth to create a mold.
- Device Description: The device is described as an impression material composed of base and catalyst pastes. This is consistent with materials used for creating physical impressions.
- Lack of In Vitro Testing: The description of performance studies focuses on physical and technical characteristics of the material and biocompatibility tests. There is no mention of testing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such testing.
- Anatomical Site: The anatomical site is "in the mouth," which is where the physical impression is taken.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function. It is a material used in a dental procedure.
N/A
Intended Use / Indications for Use
Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Position® Penta, Position® Penta Quick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Ouick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of: (1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k). They are intended for use with an electronic mixing apparatus (Pentamix®) to be used table-side.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Impressions for opposing jaws.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To support substantial equivalence to the predicate product, the physical and technical characteristics of Position® Penta and Position® Penta Quick have been compared to those of Dimension® Penta H. Position® Penta and Position® Penta Quick meet the requirements of relevant DIN, ISO and ADA standards for impression material.
Biocompatibility tests, including cytotoxicity, AMES, skin irritation, eye irritation, acute oral toxicity, and sensitization, have been undertaken on the new form of ingredient (i.e., differing in chemical structure) used in the Position® Penta and Position® Quick base paste, and also on final ESPE products containing that ingredient.
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.
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
§ 872.3660 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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JAN 2 9 1998
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be 'K974231'. The handwriting is somewhat messy, but the characters are still legible. The image is in black and white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS II.
ESPE is submitting a 510(k) premarket notifications to its 510(k) submission for polyvinyl siloxane impression material, tradenamed Dimension® Penta (K960547), now called Dimension® Penta H.4 The modifications have been made to create slightly modified impression materials, referred to by the tradenames Position® Penta and Position® Penta Quick. Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.
ESPE is claiming substantial equivalence to its previously cleared impression material, Dimension® Penta H. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same basic intended use: taking impressions in the mouth. All three products are intended for use with an electronic mixing apparatus (Pentamix®) to be used table-side. Position® Penta, Position® Penta Ouick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of:
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When ESPE's 510(k) was filed and cleared, the product was tradenamed Dimension® 1/ Penta. Subsequent to that time, the product name was changed to Dimension® Penta H to indicate "high consistency." At the time the 510(k) for Dimension® Penta was cleared. ESPE did not offer a low consistency version of the product, as it does now (Dimension® Penta L).
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(1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k). To support substantial equivalence to the predicate product, the physical and technical characteristics of Position® Penta and Position® Penta Quick have been compared to those of Dimension® Penta H. Position® Penta and Position® Penta Quick meet the requirements of relevant DIN, ISO and ADA standards for impression material.
Biocompatibility tests, including cytotoxicity, AMES, skin irritation, eye irritation, acute oral toxicity, and sensitization, have been undertaken on the new form of ingredient (i.e., differing in chemical structure) used in the Position® Penta and Position® Penta Quick base paste, and also on final ESPE products containing that ingredient.
ESPE's 510(k) has been submitted on November 12, 1997, by Dr. Barbara Wagner-Schuh at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, specifically the symbol associated with the U.S. Department of Health & Human Services (HHS). The symbol features a stylized caduceus-like design with three intertwined figures or shapes, representing the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HO" is partially visible, indicating the full text would likely read "DEPARTMENT OF HEALTH & HUMAN SERVICES."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1998 1998
Dr. Barbara Wagner-Schuh Regulatory Affairs ESPE Dental-Medizin GmbH & Company KG AM Griesberg 2 Seefeld, OBB., GERMANY
Re : K974231 Trade Name: Position Penta, Position Penta, Quick Requlatory Class: II Product Code: ELW Dated: November 4, 1997 Received: November 12, 1997
Dear Dr. Waqner-Schuh:
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 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 general controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Register. Please note: this response to your premarket notification submission does
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not affect any obligation you might have under sections 531 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Position® Penta Device Name: Position® Penta Quick
Indications for Use:
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- Impressions for temporary restorations .
- Preliminary impressions (all types) .
- Impressions of opposing jaws .
- Impressions for orthodontic models .
Susan Russer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospi 510(k) Number - 1970 .. .. . .
Prescription Use _____________
or
Over-the Counter Use _________________________________________________________________________________________________________________________________________________________
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