(90 days)
Not Found
No
The summary describes physical dental implants and their intended use and performance based on bench, animal, and literature review, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "oral rehabilitation of edentulous and partially dentate patients" and to "restore chewing function," which are therapeutic purposes as they treat a patient's condition and improve their health and function.
No
The document describes dental implants used for functional and aesthetic rehabilitation, and their physical specifications. It does not mention any diagnostic functions, only their use in treatment.
No
The device description explicitly lists physical components (dental implants of various sizes and materials) and the performance studies focus on bench, animal, and clinical literature related to these physical implants. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant for oral endosteal implantation to restore chewing function and aesthetics. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description lists various types and sizes of dental implants, which are physical devices implanted into bone.
- 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. The device itself is the therapeutic intervention.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body for functional and aesthetic restoration.
N/A
Intended Use / Indications for Use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Product codes
DZE
Device Description
The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw 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)
The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and continues to be representative of the performance of the subject devices.
A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. We also provide consensus statements from the American Dental Association, the McGill Consensus and the York Consensus indicating that two implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033922, K033984, K053088, K062129, K081419, K083550, K111357, K121131, K122855, K123784
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
K1302222
Traditional 510(k) Submission.
Change in Straumann Dental Implant Indications for Use
APR 2 9 2013
5. 510(k) Summary
Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Contact Person: | Jennifer M. Jackson, MS or | Christopher Klaczyk |
|---|---|---|
| Phone Number: | 1-978-747-2509 | 1-978-747-2575 |
| Fax Number: | 1-978-747-0023 | 1-978-747-0023 |
Date of Submission: 28-Jan-2013
5.1 Name of the Device
| Trade Name: | Straumann® Dental Implant System |
|---|---|
| SLActive and Roxolid Product Families |
Common Name: Dental Implants
Classification Name: Implant, Endosseous, Root-form
Regulation Number: §872.3640
5.2 Predicate Device(s)
K033922, Modification to ITI Dental Implant System
K033984, ITI Dental Implant System
K053088, SLActive Implants
K062129, P.004 Implants
K081419, Modified Dental Implant
K083550, Modified Dental Implant
K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System
K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants
K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants
K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families
1
Traditional 510(k) Submission
Change in Straumann Dental Implant Indications for Use
Device Description 5.3
The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm
5.4 Indications For Use / Intended Use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
5.5 Technological Characteristics
The subject devices are identical to the corresponding Straumann predicate devices as far as design, materials, surface treatments, fundamental operating principles, and sterilization processes and procedures. The change proposed in this premarket notification modifies the Indications for Use for the SLActive® and Roxolid® dental implants.
There are no changes to or new surgical instruments or secondary components being introduced as a result of the proposed change.
5.6 Performance Testing
The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and continues to be representative of the performance of the subject devices.
A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. We also provide
2
Change in Straumann Dental Implant Indications for Use
consensus statements from the American Dental Association, the McGill Consensus and the York Consensus indicating that two implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.
5.7 Conclusion
The documentation submitted in this premarket notification supports the proposed modification to the Indications for Use of the SLActive® and Roxolid® dental implants. The subject devices are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002
April 29, 2013
Ms. Jennifer M. Jackson, MS Senior Regulatory Affairs Project Manager Straumann USA, Limited Liability Company 60 Minuteman Road ANDOVER MA 01810
Re: K130222
Trade/Device Name: Straumann® Dental Implant System SLActive and Roxolid Product Families Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2013 Received: January 29, 2013
Dear Ms. Jackson:
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
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21-GFR-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/Medica!Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S for
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 (if known); K130222
Device Name:
Straumann® Dental Impiant System SLActive and Roxolid Product Families
Indications for Use:
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) |
|---|
| -------------------------------------------------------- |
| Digitally signed by Mary S. Runner - S | |
|---|---|
| ON: c=US, o=U.S. Government, | |
| ou=HHS, ou=FDA, ou=People, | |
| cn=Mary S. Runner - S, | |
| 0.9.2342.19200300.100.1.1=13000879 | |
| Date: 2013.04.29 09:55:02 -04'00' |
Susan Runner, DDS, DA
Division Sign-Off) (Division Sign-Sill)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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