(98 days)
Not Found
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dental implant system intended to restore esthetics and chewing function by supporting prosthetic devices, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate that the DenovisMed Dental Implant System is used for supporting crowns, bridges, and overdentures in edentulous or partially edentulous patients to restore esthetics and chewing function, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of a dental implant, abutments, and prosthetic components, which are physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the DenovisMed Dental Implant System is intended to be surgically placed in the jawbone to support prosthetic devices (crowns, bridges, overdentures) and restore chewing function and esthetics. This is a device that is implanted into the body, not used to test samples from the body.
The information provided describes a dental implant system, which is a type of medical device used in dentistry for surgical implantation.
N/A
Intended Use / Indications for Use
For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.
Product codes
DZE, NHA
Device Description
The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxillary and or mandibular arches
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)
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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.
Not Found
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).
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§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
DenovisMed Dental Implant System
510(k) Summary
MAR 6 2009
Denovis Medical, LLC DenovisMed Dental Implant System
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Denovis Medical, LLC
1121 N. Bethlehem Pike, Suite 60-104
Spring House, Pennsylvania 19477, USA
Telephone: +1 (215) 654-0177
Fax: +1 (215) 654-0178 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Roger Ranck
Denovis Medical, LLC
Telephone: +1 (215) 654-0177
Fax: +1 (215) 654-0178
email: rranck@denovismed.com |
| Representative/Consultant: | Kevin A. Thomas
Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200 |
San Diego, CA 92130
Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
DenovisMed Dental Implant System Trade/Proprietary Name: Dental implant; Dental implant abutment Common Name: Implant, endosseous, root-form; Classification Regulations: Endosseous dental implant abutment 21 CFR 872.3640, 21 CFR 872.3630 Class II DZE; NHA Product Codes Dental Products Panel Classification Panel: Dental Devices Branch Reviewing Branch:
510(k) Summary
ﻬﺎ
1
510(k) Summary
INTENDED USE
For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.
DEVICE DESCRIPTION
The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.
EQUIVALENCE TO MARKETED DEVICE
Denovis Medical, LLC demonstrated that, for the purposes of FDA's regulation of medical devices, the DenovisMed Dental Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the DenovisMed Dental Implant System has the following similarities to the predicate devices:
- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same materials, and .
- has similar packaging and is sterilized using the same materials and processes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Denovis Medical, LLC C/o Kevin A. Thomas, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K083543
Trade/Device Name: DenovisMed Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 11, 2009 Received: February 12, 2009
Dear Dr. Thomas:
This letter corrects our substantially equivalent letter of March 6, 2009.
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 (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 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- Dr. Thomas
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Bunner
Susan Runner, DDS, MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
DenovisMed Dental Implant System
Indications for Use
510(k) Number (if known): K083543
DenovisMed Dental Implant System Device Name:
Indications for Use:
For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
200
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Divisa
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ﺮﺍﻧﺪ ۳۰۰ ﺗﻮﺍﻧﻪ ! Division (Divisity Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthasiology, Gearn. . . . . . . . . . . . . . . . . Infection Control. Dental Devices
510(k) Number: K083543