(217 days)
No
The document describes dental abutments and their mechanical testing, with no mention of AI or ML.
No.
The device is described as an abutment intended to support prosthetic devices (bridges, overdentures, single/multiple tooth prostheses, or final restorations) in conjunction with dental implants, rather than directly treating a medical condition or disease.
No
The provided text describes dental abutments for supporting prosthetic devices (bridges, overdentures, prostheses, crowns). This is a purely structural and restorative function, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly details physical components (abutments with specific diameters, angles, and gingival heights) and mentions mechanical strength testing according to ISO 14801, which is a standard for testing physical dental implants. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in conjunction with dental implants to support bridges or overdentures and support prosthetic devices. This is a structural and mechanical function within the body.
- Device Description: The description details the physical characteristics of the abutments, such as platform diameters, angles, and gingival heights. This aligns with a medical device used for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device described is a dental abutment, which is a type of medical device used in dentistry to connect a dental prosthesis (like a crown, bridge, or denture) to a dental implant. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The AtlantisTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.
Product codes
NHA
Device Description
OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm).
OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.
Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches, mandible or maxilla
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)
Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
510(k) Summary
JAN 2 3 2013
Astra Tech AB OsseoSpeed™ Angled Abutment EV K121810
January 23, 2013
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 +46 31 776 30 00 Telephone: +46 31 776 30 10 Fax:
Official Contact:
Representative/Consultant:
Christina Lewing Head of Regulatory Affairs
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: Common Name: Classification Name: Classification Regulation: Product Code: Classification Panel: Reviewing Branch:
OsseoSpeed™ Angled Abutment EV Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
1
INTENDED USE
OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The AtlantisTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.
DEVICE DESCRIPTION
OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm).
OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.
Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.
EQUIVALENCE TO MARKETED DEVICE
OsseoSpeed™ Angled Abutment EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Astra Tech AB - K111287 Astra Tech, Inc. - K112138 Astra Tech, Inc. - K110356
2
The purpose of this submission is to expand the OsseoSpeed Plus implant system to include three new components, the OsseoSpeed Angled Abutment EV, the Atlantis Abutment in Zirconia for OsseoSpeed EV, and Atlantis Crown Abutment in Zirconia for OsseoSpeed EV.
OsseoSpeed Angled Abutment EV is provided in two angles (20° and 30°). Platform sizes correspond to OsseoSpeed Plus implant diameters cleared in K111287. OsseoSpeed Angled Abutment EV is indicated for multi-unit restorations as are the predicate devices.
The original Atlantis Abutment in Zirconia for OsseoSpeed Plus was cleared in K112138 and the Atlantis Crown Abutment in Zirconia for OsseoSpeed in K110356. The interface remains the same as in K112138. A new size of Ø5.4 mm has been added for both designs.
Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices.
Overall, OsseoSpeed Angled Abutment EV 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 or very similar 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 & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2013
Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130
Re: K121810
Trade/Device Name: OsseoSpeed 110 Angled Abutment EV Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 2, 2013 Received: January 3, 2013
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.
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,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K)21810
OsseoSpeed™ Angled Abutment EV Device Name:
Indications for Use:
OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic I he Atiantis - I Duanon in intelly edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to The Attamily - Crown Fre that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.
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)
Page 1 of 1
Sheena A. Green 2013.01.23 16:10:12 -05/00
Division Sign Off) (Division Sign-Off)
Division of Anesthestology, General Hospital Division of Anton, Dental Devices
510(k) Number