(72 days)
Not Found
No
The summary describes a purely mechanical device (titanium screw) and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is a screw used as an anchor for orthodontic procedures, which is a structural aid rather than a device that treats a disease or condition.
No
The device is described as a screw intended for use as an anchor in orthodontic procedures, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it consists of a "titanium screw," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the screws are "surgically placed in the mouth for use as an anchor for orthodontic procedures in patients." This describes a device used in vivo (within the body) for a therapeutic purpose (orthodontic movement).
- Device Description: The description of a "titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point" further reinforces its function as an implantable device used directly on the patient.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic or other information. This device is used in vivo as a physical anchor.
N/A
Intended Use / Indications for Use
The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures.
The KLS-Martin Ortho Anchorage System are screws intended to be surgically placed in The RES Martin Orate anchor for orthodontic procedures in patients.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
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)
Not Found
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.
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
JAN 1 5 2004
૪૦૨ ૩૫૪૩
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | |
| Device Name: | KLS-Martin Ortho Anchorage System |
| Trade Name: | Ortho Anchorage System |
| Common Name: | Endosseous Implant Screw |
| Classification
Name and Number: | Endosseous Implant (CFR 872.3640) |
| Regulatory Class: | Class III |
| Predicate Devices: | Centre-Drive Drill Free Screw
(K971297)
Nobel Biocare Onplant Orthodontic System
(K980460) |
| Device
Description: | The KLS-Martin Ortho Anchorage System consists of
a titanium screw designed to aid in dental movement
by providing a rigid skeletal fixation point. |
| Intended Use: | The KLS-Martin Ortho Anchorage System is intended
to be surgically placed in the mouth for use as an
anchor for orthodontic procedures. |
1
Technological Characteristics:
Similarities to Predicate
Screws are similar to KLS-Martin Centre-Drive Drill Free Screw (K971297)
Anchorage screws are either commercially pure (CP) titanium or Ti-6AL-4V Titanium Alloy.
Differences to Predicate
KLS-Martin Centre-Drive Drill Free Screw (K971297) is intended for plate fixation across fractures or The Ortho Anchorage System is osteotomies. designed to aid in dental movement by providing a rigid skeletal fixation point.
Substantial Equivalence:
The KLS-Martin Ortho Anchorage System is substantially equivalent in application and function to the KLS Martin Centre-Drive Drill Free Screw (K971297)
The KLS-Martin Ortho Anchorage System is THE REO Marantially equivalent in intended use to the Nobel Biocare Onplant Orthodontic System (K980460)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features 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 pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Jennifer Damato Director Regulatory Affair Quality Assurance KLS-Marin, L.P. 11239-1 Street Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K033483
Trade/Device Name: KLS-Martin Ortho Anchorage System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 3, 2003 Received: November 4, 2003
Dear Ms. Damato:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your securermined the device is substantially equivalent (for the referenced above and have acteringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce proces that have been reclassified in accordance with the provisions of Amendinens, or to de rough and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar F ood, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provinces of an annual 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 Mry, it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or ou found in ther announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Damato
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be advisod that I Da determination that your device complies with other requirements Incall that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I outstal statis requirements, including, but not limited to: registration r our indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in all qt radiation 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) I mis letter will and w yourse of substantial equivalence of your device to a premarket notification - I device results in 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), please contact the Office of Compliance at (301) 594-4613 preculation entitled, "Misbranding by reference to premarket notification" (21CFR Part 16 gated on the new obtain other general information on your responsibilities under the Act 607.977. Tourinaly of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Cluts
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
4
Indications for Use
510(k) Number (if known): K033483
Device Name: KLS-Martin Ortho Anchorage System
Indications For Use:
The KLS-Martin Ortho Anchorage System are screws intended to be surgically placed in The RES Martin Orate anchor for orthodontic procedures in patients.
AND/OR Prescription Use يري (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunno
Page 1 of
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital. Division Control, Dental Devices
510(k) Number: K083403