(517 days)
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No
The description focuses on the material composition and clinical applications of dental composites, with no mention of AI or ML capabilities.
No
The devices are restorative materials (composites) used for filling cavities and other dental applications, not therapeutic devices that treat a disease or condition.
No
The document describes dental filling materials (composites), which are used for treatment and restoration, not for diagnosing conditions.
No
The device description is not provided, but the intended use clearly describes light-curing composite materials used for dental fillings and restorations. These are physical materials, not software.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended uses described for all the listed products (Capo Hybrid, Capo Flow, Capo Natural, Capo Slow Flow, Capo Universal, NanoPaq Flow, NanoPaq) are for direct dental restorations and procedures performed within the mouth. This includes filling cavities, sealing fissures, creating inlays/onlays, splinting teeth, and adjusting aesthetics.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The procedures described for these dental composites do not involve the examination of such specimens.
- Lack of IVD Characteristics: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
These devices are clearly intended for direct clinical use within the oral cavity for restorative and aesthetic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre. Applications are:
- Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities.
- Indirect restorations such as inlays, onlays and laminate veneers.
- Extended fissure sealing in molars and premolars.
- Endodontic posts.
- Splinting mobile teeth.
- Adjusting the contours and shades to improve aesthetics.
Capo Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are:
- Fissure sealing.
- Extensive fissure sealing on molars and premolars.
- Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects).
- Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal loads.
- Minimally invasive fillings in Black's class III cavities.
- Restoring defects in enamel.
- Blocking out undercuts.
- Minimal adjustments to the contours and shade of the enamel.
Capo Natural is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are:
- Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities.
- Indirect restorations such as inlays, onlays and laminate veneers.
- Extended fissure sealing in molars and premolars.
- Endodontic posts.
- Splinting mobile teeth.
- Adjusting the contours and shades to improve aesthetics.
Capo Slow Flow is a light-curing, flowable, highly radiopaque (210 % Al) composite with a high viscosity. Applications are:
- Fissure sealing.
- Extensive fissure sealing on molars and premolars.
- Fillings in Black's class V (cervical caries, root erosions, v-shaped lesions).
- Minimally invasive fillings in Black's classes I, II and III.
- Corrections of enamel defects.
- Blocking out undercuts.
- Small corrections of shape and colour of the enamel.
Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are:
- Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities.
- Indirect restorations such as inlays, onlays and laminate veneers.
- Extended fissure sealing in molars and premolars.
- Endodontic posts.
- Splinting mobile teeth.
- Adjusting the contours and shades to improve aesthetics.
NanoPaq Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are:
- Fissure sealing.
- Extensive fissure sealing on molars and premolars.
- Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects).
- Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal loads.
- Minimally invasive fillings in Black's class III cavities.
- Restoring defects in enamel.
- Blocking out undercuts.
- Minimal adjustments to the contours and shade of the enamel.
NanoPaq is a light-curing nano-composite for the adhesive filling technique. It contains an ultrafine, radiopaque glass filler. Applications are:
- Direct anterior and posterior tooth restorations in Black's classes I, II, III, IV, and V.
- Indirect restorations such as inlays, onlays and veneers.
- Extended fissure sealing on molars and premolars.
- Building up stumps.
- Splinting of loosened teeth.
- Corrections of shape and colour to enhance aesthetics.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBC, EMA
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
Schutz Dental Gmbh Antje Maurer International Sales Director Dieselstrasse 5-6 Rosbach, DE 61191 GERMANY
Re: K151399
Trade/Device Name: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Pag Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Codes: EBF, EBC, EMA Dated: May 22, 2015 Received: Mav 26, 2015
Dear Antje Maurer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runne DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K151399 Device Name: Capo Hybrid Indications for Use:
Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre. Applications are:
- . Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities.
- Indirect restorations such as inlays, onlays and laminate veneers. 0
- o Extended fissure sealing in molars and premolars.
- Endodontic posts .
- . Splinting mobile teeth.
- Adjusting the contours and shades to improve aesthetics. .
Prescription Use _ V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_of 1_
3
510(k) Number (if known): K151399 Device Name: Capo Flow Indications for Use:
Capo Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are:
- Fissure sealing .
- Extensive fissure sealing on molars and premolars .
- Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects) .
- Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal . loads
- . Minimally invasive fillings in Black's class III cavities
- 0 Restoring defects in enamel
- Blocking out undercuts 0
- 0 Minimal adjustments to the contours and shade of the enamel
Prescription Use _ V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Number (if known): K151399 Device Name: Capo Natural Indications for Use:
Capo Natural is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are:
- Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities. .
- 0 Indirect restorations such as inlays, onlays and laminate veneers.
- Extended fissure sealing in molars and premolars. .
- Endodontic posts. .
- Splinting mobile teeth. .
- Adjusting the contours and shades to improve aesthetics. 0
Prescription Use _ V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
510(k) Number (if known): K151399 Device Name: Capo Slow Flow Indications for Use:
Capo Slow Flow is a light-curing, flowable, highly radiopaque (210 % Al) composite with a high viscosity. Applications are:
- Fissure sealing .
- 0 Extensive fissure sealing on molars and premolars
- Fillings in Black's class V (cervical caries, root erosions, v-shaped lesions) .
- Minimally invasive fillings in Black's classes I, II and III
- 0 Corrections of enamel defects
- . Blocking out undercuts
- . Small corrections of shape and colour of the enamel
Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6
510(k) Number (if known): K151399 Device Name: Capo Universal Indications for Use:
Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are:
- Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities. .
- 0 Indirect restorations such as inlays, onlays and laminate veneers.
- Extended fissure sealing in molars and premolars. .
- Endodontic posts. .
- Splinting mobile teeth. 0
- 0 Adjusting the contours and shades to improve aesthetics.
Prescription Use _ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
7
510(k) Number (if known): K151399 Device Name: NanoPag Flow Indications for Use:
NanoPaq Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are:
- Fissure sealing ಲ್ಲ
- Extensive fissure sealing on molars and premolars .
- Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects) 0
- Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal . loads
- 0 Minimally invasive fillings in Black's class III cavities
- Restoring defects in enamel 0
- . Blocking out undercuts
- Minimal adjustments to the contours and shade of the enamel .
| 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 OF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)
8
510(k) Number (if known): K151399 Device Name: NanoPag Indications for Use:
NanoPaq is a light-curing nano-composite for the adhesive filling technique. It contains an ultrafine, radiopaque glass filler. Applications are:
- Direct anterior and posterior tooth restorations in Black's classes I, II, III, IV, and V. .
- Indirect restorations such as inlays, onlays and veneers. 0
- Extended fissure sealing on molars and premolars. 0
- Building up stumps. .
- Splinting of loosened teeth. .
- Corrections of shape and colour to enhance aesthetics. 0
Prescription Use _ V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)