(148 days)
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No
The document describes a dental implant system and its intended use, focusing on materials, surgical procedures, and anatomical sites. There is no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The device replaces missing masticatory functional units (teeth) and restores esthetics and chewing function, which addresses a medical condition or ailment.
No
The device description clearly states it is for supporting prosthetic devices to restore esthetics and chewing function, not for diagnosing conditions.
No
The device description explicitly mentions "implants, abutments, prosthetic components and accessories," which are physical hardware components, not software.
Based on the provided text, 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 Astra Tech Implant System is intended for replacing missing teeth in the mandible or maxilla and supporting prosthetic devices. This is a surgical and prosthetic device used directly on the patient's body, not for testing samples outside the body.
- Lack of IVD Characteristics: The text does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to disease or health conditions.
Therefore, the Astra Tech Implant System falls under the category of a surgical implant and prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.
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
mandible or maxilla
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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§ 872.3640 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.
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510(k) Summary
1
:
Astra Tech Implant System
510(k) Summary
SEP 2 2 2009
Astra Tech AB Astra Tech Implant System
Astra Tech AB
Christina Lewing
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 Telephone: +46 31 776 30 00 +46 31 776 30 10 Fax:
Official Contact:
Representative/Consultant:
Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: email: Ischulz@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
Astra Tech Implant System Dental implant, dental implant abutment Implant, endosseous, root form Endosseous dental implant abutment Class II, 21 CFR 872.3640 DZE Dental Products Panel Dental Devices Branch
INTENDED USE
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
1
The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.
DEVICE DESCRIPTION
Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.
EQUIVALENCE TO MARKETED DEVICE
Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech 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 pre-amendment devices.
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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 features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
SEP 2 2 2009
Food and Drug Adminismation 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs Pax Med International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
K091239 Re:
Trade/Device Name: Astra Tech Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 17, 2009 Received: September 18, 2009
Dear Ms. Schulz:
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 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. Schulz
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Arthur D. Little
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Astra Tech Implant System
Indications for Use:
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone; immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Kein Marly for MSR
(Division Sign-Off)
Page 1 of
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091239