(143 days)
Not Found
No
The document describes dental implants and abutments, focusing on their physical characteristics, materials, and intended use in surgical procedures. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The included radiographic implant guide sheets are simple physical tools for planning, not digital or AI-powered.
No
The device is described as an implant system (implants and abutments) used to replace missing teeth and provide support for crowns, bridges, or overdentures. While it helps restore function, it is not primarily intended to treat or cure a disease or medical condition, which is the definition of a therapeutic device.
No
This device is a dental implant system (implants and abutments) used to replace missing teeth, not to diagnose a condition.
No
The device description clearly outlines physical components like implants, abutments, cover screws, and healing abutments, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a dental implant system, including implants and abutments, intended for surgical placement in the mandible or maxilla to replace missing teeth.
- Intended Use: The intended use is for surgical procedures and providing support for dental prosthetics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
This device is a medical device, specifically a dental implant system, used for surgical and restorative purposes within the human body.
N/A
Intended Use / Indications for Use
OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:
- · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
- · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
- · For both one- and two-stage surgical procedures
- · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
- · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Product codes
DZE, NHA
Device Description
OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.
OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.
To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101732, K091239, K053384, K083496
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
SEP 2 6 2011
Astra Tech AB Astra Tech Implant System Plus
K11287
September 26, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Astra Tech AB |
|---|---|
| Aminogatan 1, P.O. Box 14 | |
| Mölndal, Sweden SE-431-21 | |
| Telephone: +46 31 776 30 00 | |
| Fax: +46 31 776 30 10 | |
| Official Contact: | Christina Lewing |
| Head of Regulatory Affairs | |
| Representative/Consultant: | Linda K. Schulz, BSDH, RDH |
| Kevin A. Thomas, PhD | |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone: +1 (858) 792-1235 | |
| Fax: +1 (858) 792-1236 | |
| email: lschulz@paxmed.com | |
| kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Astra Tech Implant System Plus |
|---|---|
| Component Name: | OsseoSpeed™ Plus implants and abutments |
| Common Name: | Dental implant and abutment |
| Classification Regulations: | Implant, endosseous, root form |
| Endosseous dental implant abutment | |
| Class II, 21 CFR 872.3640 | |
| Product Code: | DZE, NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
1
510(k) Summary
INTENDED USE
OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:
- · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
- · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
- · For both one- and two-stage surgical procedures
- · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
- · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
DEVICE DESCRIPTION
OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.
OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.
To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.
2
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 the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Astra Tech AB, Astra Tech Implant System cleared under K101732,
Astra Tech AB, Astra Tech Implant System cleared under K091239.
Astra Tech Inc., Fixture MicroThread™ OsseoSpeed™ cleared under K053384, and
Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496.
The subject device and the predicate devices have intended use, have the same technological characteristics and are made of the same materials. They encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. The technological change from the Astra Tech Implant System OsseoSpeed implants is the new anti-rotation feature of keyway cross section connections which is similar to the cam anti-rotation mechanism of the CAMLOG Implant System. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
The Astra Tech 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs Paxmed International, LLC 11234 Camino Real. Suite 200 San Diego, California 92130
SEP 2 2011
Re: K111287
Trade/Device Name: Astra Tech Implant System Plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE, NHA Product Code: 11 Dated: September 13. 2011 Received: September 14, 2011
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. 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.
4
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.
ff 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/ucm 115809.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 10 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,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number: K111287
Device Name: Astra Tech Implant System Plus
Indications for Use:
Implants:
OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:
- · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
- · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
- · For both one- and two-stage surgical procedures
- · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
- · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
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)
Susan Ruse
Page 1 of 1
Division Sign-Off)
Division of Anesthesiology, General Hospital
fection Control, Dental Devices
510(k) Number: K111287