(98 days)
Not Found
No
The summary describes a mechanical orthodontic screw and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used to facilitate orthodontic movement of teeth, which is a structural correction rather than a direct treatment of a disease or condition for therapeutic purposes.
No
Explanation: The device is intended to provide an anchorage point for orthodontic appliances to facilitate tooth movement, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of "self tapering titanium grade 5 (Ti6A14V) screws," which are physical hardware components.
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 device is for providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed in vivo (within the body).
- Device Description: The device is described as titanium screws, which are physical implants.
- 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.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo as a physical anchor.
N/A
Intended Use / Indications for Use
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Dual Top Anchor Systems Screws by Jeil Medical Corporation, Reference number K033767
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
SEP 1 9 2005
Image /page/0/Picture/3 description: The image shows the logo for Lancer Orthodontics. The word "LANCER" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "ORTHODONTICS". Above the word "LANCER" is a curved line that resembles a comet tail.
SUMMARY
Submitter's name: Address:
Phone: Fax number: Name of contact person: Lancer Orthodontics 253 Pawnee Street San Marcos, CA 92078 760-744-5585 760-744-5842 Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
| Date the summary was prepared: | June 7, 2005 |
|---|---|
| Name of the device: | O.A.S.I. System |
| Trade or proprietary name: | O.A.S.I. System |
| Common or usual name: | Mini Screws |
| Classification name: | Endosseous dental implant |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Dual Top Anchor Systems Screws by Jeil Medical Corporation, Reference number K033767.
Description of the device:
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
Indications:
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
1
Summary of the technological characteristics of our device compared to the predicate device:
The predicate Dual Top Anchor Systems Screws by Jeil Medical Corporation, K033767 and O.A.S.I. System microscrews were compared in the following areas and found to have similar technological characteristics and therefore to be equivalent.
Indications For Use Target Population Design Materials Sterility Biocompatibility Anatomical Sites Where Used Standards Met
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, possibly representing a human figure or a flame. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2005
Lancer Orthodontics, Inc. C/O Ms. Grace Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606
Re: K051552
Trade/Device Name: O.A.S.I. System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: August 24, 2005 Received: August 26, 2005
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives that the Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Ocennens , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condois provisions of the From Fion , 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 If your device is classified (boo as additional controls. Existing major regulations affecting (FMA), it may oc subject to Sach adam Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Holland
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualler of a substantial vith other requirements
mean that FDA has made a determination that your device complies with of connects mean that FDA has made a deceminations administered by other Federal agencies. of the Act of ally receital statutes and regaraters, including, but not limited to: registration You must comply with an the Act 8 requires (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), labeling (21 cms (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 12, of requirements as set form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a premarket nothfication. The PDF maing or 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 advice for your de at (240) 276-0115. Also, please note the regulation please contact inc Other or Ochiphian promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on consumer Assistance at its toll-free DIVIsion of Small Partier (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clive
St. Ives, 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
4
Indications for Use
510(k) Number (if known): 《OS 1552
Device Name: O.A.S.I. System
Indications For Use:
This device is intended to provide a fixed anchorage point for attachment of This device is intended to provide a mod antic movement of teeth. It is
orthodontic appliances to facilitate the orthodontic movement has heen orthodonlic appliances to faolikato the orthodontic treatment has been completed. Screws are intended for single us only.
AND/OR Over-The-Counter Use Prescription Use __ > (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
(Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Division Control, Dental Devi
510(k) Number:
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REGULATORY SPECIALISTS, INC.