(80 days)
K07185
Not Found
No
The description focuses solely on the physical characteristics and intended use of a dental implant screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an "anchorage point" for orthodontic appliances to facilitate "orthodontic movement of the teeth." It is a mechanical aid for treatment, not a device that directly or by itself provides therapy.
No
The device is described as a "threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth." Its purpose is to provide mechanical support for orthodontic treatment, not to diagnose a condition.
No
The device description clearly states it is a "threaded titanium dental implant screw" and a "titanium fixation device," indicating it is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The Sterile Self Ligating Spider Screw is a physical implant inserted into the body (the upper or lower jaws) to provide anchorage for orthodontic appliances. It is a mechanical device used for structural support and movement facilitation, not for testing or analyzing biological samples.
The description clearly indicates it's a dental implant screw used for a physical purpose within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
The Indications for use are substantially unchanged compared with K071851. The only changes are relevant to the fixation instructions of the Sterile Self Ligating Spider Screw: these instructions are added to the predicate's one.
Product codes (comma separated list FDA assigned to the subject device)
OAT
Device Description
The Sterile Self Ligating Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Self Ligating Spider Screw is provided in "Self Drilling and Self Tapping" configuration and is manufactured from Grade 5 Titanium alloy according to ASTM F136-98 standard. Sterile Self Ligating Spider Screw is provided with different diameters. lengths and head shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaws
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.
K07185
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
KOR1390
HDC S.r.l. SPECIAL 510(K) Notification Sterile Self Ligating Spider Screw
ﻟ
510(k) Summary for the
JUL 3 0 2009
1
Sterile Self Ligating Spider Screw
This Special 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
General Information
ﺗ
Submitter:
HDC S.r.l. Via dell'Industria, 19 36060 - SARCEDO (Vicenza) - Italy Tel: +39 0445 364 148 Fax: +39 0445 383 645
Establishment Registration Number: 3005728057
Contact Person:
Guido Bonapace (consultant) ISEMED srl Via Borgo Santa Cristina, 12 40026 Imola (BO) Italy Mob.phonc: +39-335-537 8686 Telephone: +39-051-625 7315 Fax: +39-051-628 4344 Email: gbonapace@isemed.eu
Summary Preparation Date:
April 30, 2009
Names
Device Name: Classification Name: Product Code: Regulation Number: Device Class:
Sterile Self Ligating Spider Screw Endosseous dental implant OAT 872.3640 Class II
17 Page
006
1
HDC S.r.l. SPECIAL 510(K) Notification
Device Description
The Sterile Self Ligating Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Self Ligating Spider Screw is provided in "Self Drilling and Self Tapping" configuration and is manufactured from Grade 5 Titanium alloy according to ASTM F136-98 standard. Sterile Self Ligating Spider Screw is provided with different diameters. lengths and head shapes.
Predicate Devices
The Sterile Self Ligating Spider Screw is substantially equivalent to the following predicate device, which is legally marketed in the United States:
| and and surface and the first and states of the high show hanner many by first and the first and the first and the first and the first and the first and the first and the fir
1
| ADDlicant | Device name | 510(k) Number |
|---|---|---|
| HDC S.r.1. | ||
| MAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | HDC Sterile Spider Screw | K07185 |
The components of Sterile Self Ligating Spider Screw have been compared in terms of intended use, design characteristics, and safety solutions with the predicate device. Complete substantial equivalence information is provided in the Section XI of this submission.
Intended Use
The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
The Indications for use are substantially unchanged compared with K071851. The only changes are relevant to the fixation instructions of the Sterile Self Ligating Spider Screw: these instructions are added to the predicate's one.
Fundamental Scientific Technology
The Sterile Self Ligating Spider Screw does not introduce changes compared with the predicate device with regards to the Fundamental Scientific Technology.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUL 3 0 2009
HDC S.r.l. C/O Mr. Guido Bonapace Regulatory Consultant ISEMED S.r.l. Via Borgo Santa Cristina, 12 40026 Imola (BO) ITALY
Re: K091390
Trade/Device Name: Sterile Self Ligating Spider Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: June 30, 2009 Received: July 2, 2009
Dear Mr. Bonapace:
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.
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.
3
Page 2- Mr. Bonapace
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Siser Grover
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Sterile Self Ligating Spider Screw
HDC S.r.l. SPECIAL 510(K) Notification
INDICATIONS FOR USE STATEMENT
Special 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________ K091390_
Device Name: Sterile Self Ligating Spider Screw
Indications for Use:
The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) UDY (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number:
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