(117 days)
No
The summary focuses on the physical characteristics and surface modifications of dental implants, with no mention of AI or ML technology.
Yes
The device is a dental implant that restores chewing function, which is a therapeutic purpose.
No
Explanation: This device is a dental implant, which is used to restore chewing function. It is a prosthetic device, not one that is used to diagnose a condition.
No
The device description clearly states it is a dental implant, which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a dental implant intended for surgical placement in the jawbone to restore chewing function. This is a surgically implanted device, not something used to test bodily specimens.
The description focuses on the physical characteristics of the implant, its surgical placement, and its function in supporting teeth. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
For immediate or delayed placement in the maxillary and/or mandibular arches to support crowns, bridges and overdentures in edentulous or partially edentulous patients.
SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
Product codes
DZE
Device Description
The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched and modified as described in K033984. No changes to overall implant design or dimensions were made. This submission involved additional studies to support the benefits of the SLActive implant surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies. The SLActive surface has faster implant secondary stability in the early healing period of 2 to 4 weeks after implant placement when compared to the SLA surface.
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
§ 872.3640 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
4653088
510(k) Summary
FEB 2 7 2006
Applicant's Name and Address 1.
Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 978-747-2500 Telephone Number: Fax Number: 978-747-0031 Contact Person: Linda Jalbert, Vice President, Regulatory and Clinical Affairs
2. Name of the Device
| Trade Name: | Straumann Dental Implant System® |
|---|---|
| Common Name: | Dental Implant |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
ITI Dental Implant System (K971578, K033984)
4. Description of the Device
The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched and modified as described in K033984. No changes to overall implant design or dimensions were made. This submission involved additional studies to support the benefits of the SLActive implant surface.
5. Intended Use of the Device
For immediate or delayed placement in the maxillary and/or mandibular arches to support crowns, bridges and overdentures in edentulous or partially edentulous patients.
6. Basis for Substantial Equivalence
The subject dental implants are identical to the currently marketed Straumann dental implants in intended use, material and design. The subject SLActive dental implants have the same indications for use as the currently marketed Straumann dental implants. The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies. The SLActive surface has faster implant secondary stability in the early healing period of 2 to 4 weeks after implant placement when compared to the SLA surface.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing medicine and health. The seal is in black and white.
Public Health Service
FEB 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Ms. Linda Jalbert Vice President Straumann Manufacturing 60 Minuteman Road Andover, Massachusetts 01810
Re: K053088
Trade/Device Name: SLActive Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 24, 2006 Received: February 27, 2006
Dear Ms. Jalbert:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Antendinents, or to act , sad Cosmetic Act (Act) that do not require approval of a premarket the rederal I 600; Drag, Drag, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls provideds or a 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 such additional controls. Existing major regulations affecting (1 Wry, it may of subject to June 11, 2009 of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Jalbert
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 mean that 1 DA mas made a assess and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regirements, including, but not limited to: registration 1 our must comply with and 1100 b ong (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT rut 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) IThis letter will anow your events and in of substantial equivalence of your device to a premits to threation. - The PDF intinues a a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), if you desire specific at no Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dryslon 01 01 01 01 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sina Lung
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K
SLActive Implants Device Name:
Indications for Use:
SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function on single-tooth and/o multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Runore
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