(198 days)
Not Found
No
The document describes dental implants and abutments, focusing on their physical design, materials, and intended use in surgical procedures. There is no mention of AI or ML technology in the description, intended use, or performance studies.
Yes.
The device is an implant system, including implants and abutments, used to replace missing teeth and support prosthetic devices, which is a therapeutic function.
No
The provided text describes dental implants and abutments intended for replacing missing teeth and supporting prosthetic devices. There is no mention of the device being used for diagnosis, only for surgical and restorative purposes.
No
The device description clearly describes physical implants and abutments made of titanium alloy and zirconia, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as implants and abutments for replacing missing teeth in the mandible or maxilla. This is a surgical and prosthetic application, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical characteristics of the implants and abutments (design, materials, dimensions). This aligns with a medical device used for implantation and support, not a diagnostic device.
- 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 screening.
- Performance Studies: The performance studies mentioned are related to mechanical testing (compression-bending) of the implants and abutments, which is typical for implantable medical devices, not IVDs.
Therefore, this device falls under the category of a medical device used for surgical and prosthetic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge - · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective - · immediate and early loading for all indications - · 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 - · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components
Abutments: ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.
The ATLANTIS™ 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 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.
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.
ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The purpose of this submission is to expand the current OsseoSpeed EV Implant System (previously named OsseoSpeed Plus) to include the OsseoSpeed Profile EV implants. The OsseoSpeed EV Implant line is a part of the ASTRA TECH Implant System. The coronal contour of the OsseoSpeed Profile EV implant is designed to follow the anatomical contour of the bone and facilitate a more esthetic restoration. Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm).
Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K120414, K080156, K 103759, K 112138, K072624, K 101732, K051652, K041509
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).
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 K130999
510(k) Summary DENTSPLY Implants OsseoSpeed™ Profile EV K130999
September 23, 2013
OCT 2 5 2013
ADMINISTRATIVE INFORMATION
| Manufacturer Name | DENTSPLY Implants |
|---|---|
| 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 | |
| 12264 El Camino Real, Suite 400 | |
| 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 Regulations
Product Code Classification Panel Reviewing Branch
OsseoSpeed™ Profile EV Dental implant and abutment
Endosseous dental implant Class II, 21 CFR 872.3640
DZE, NHA Dental Products Panel Dental Devices Branch
1
INTENDED USE
Implants:
The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
- · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge
- · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective
- · immediate and early loading for all indications
- · 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
- · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components
Abutments
ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.
The ATLANTIS™ 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 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.
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.
ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.
DEVICE DESCRIPTION
The purpose of this submission is to expand the current OsseoSpeed EV Implant System (previously named OsseoSpeed Plus) to include the OsseoSpeed Profile EV implants. The OsseoSpeed EV Implant line is a part of the ASTRA TECH Implant System. The coronal contour of the OsseoSpeed Profile EV implant is designed to follow the anatomical contour of the bone and facilitate a more esthetic restoration.
2
Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm).
Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.
EQUIVALENCE TO MARKETED DEVICE
DENTSPLY Implants submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices OsseoSpeed™ Profile EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Astra Tech AB, OsseoSpeed™ Plus - K120414 Astra Tech AB, OsseoSpeed™ Profile, System - K080156 Astra Tech, Inc., Atlantis™ Abutment in Zirconia for OsseoSpeed TX Profile Implant - K 103759 Astra Tech, Inc., Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant - K 112138 Astra Tech AB, Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 101732 Atlantis Components, Inc. AtlantisTM Abutment for Astra Implant - K051652 FRIADENT GmbH, ANK YLOS® Dental Implant System - K041509
The subject device and the predicate devices have intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including diameter, length, angulation and surface treatment. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.
Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Overall. OsseoSpeed™ Profile 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 and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2013
DENTSPLY Implants C/O Linda K. Schulz, BSDH, RDH PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130
Re: KI30999
Trade/Device Name: OsseoSpeed™ Profile EV Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 23, 2013 Received: September 24, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Mary Si Bunner -S" in a simple, bold font. The text is arranged horizontally, with the name "Mary" appearing first, followed by "Si Bunner" and then "-S". The letters are uniformly sized and spaced, creating a clean and legible presentation of the name. The overall impression is straightforward and professional.
Kwame Ulmer M.S. Acting Division 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
K130999 510(k) Number:
OsseoSpeed™ Profile EV Device Name:
Implants:
The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- · replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
- · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge
- · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective
- · immediate and early loading for all indications
- · 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
- · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components
Abutments:
ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.
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 tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutnent. The abutment screw is intended to secure the abutment to the endosseous implant.
The ATLANTIS™ Crown Abutment 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.
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.
A TLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (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
Susan Runner
DOSPA 2013.10.25 08:23:13
Mary S. Runner -S
04'00"