(115 days)
No
The summary does not mention AI, ML, or any related technologies, and the device description is purely mechanical.
No
The device is a dental implant designed to restore teeth functions, not to treat or cure a disease or medical condition.
No
This device is a dental implant designed to restore partially or fully edentulous patients by supporting prostheses. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is a physical titanium screw-type threaded root-form endosseous implant, which is a hardware 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 a device designed to be surgically implanted into the jawbone to support dental prostheses. This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed for surgical placement.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Anatomical Site: The device is used within the mandible or maxilla, which are parts of the patient's body, not a specimen.
Therefore, the Intra-Lock® Implants are a medical device used for surgical implantation and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or the maxilla
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)
No new performance testing was conducted.
Mechanical bench testing of two previously identified Intra-Lock Dental Implant System worst-case scenario (i.e. smallest diameter implant / angled abutments), which remains applicable for the implants contained in this submission and was previously reviewed in K103194, April 21, 2011 and/or K111199, August 8, 2011.
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.
Intra-Lock® Dental Implant System with Blossom, K103194, BioHorizons Internal, Single-Stage and Tapered Implant Systems, K073268, K073282 & K071638
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
MAR 2 0 2014
Image /page/0/Picture/2 description: The image shows the logo for Intra-Lock International. The logo consists of the words "INTRA-LOCK" in large, bold, sans-serif font, with the word "INTERNATIONAL" in a smaller font underneath. To the left of the word "INTRA-LOCK" is a stylized square design.
510(k) SUMMARY
Submitter's Name:
| Phone: | |
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| Facsimile: | |
| Contact Person: | |
| Date Prepared: | |
| Trade Name: | |
| Common Name: | |
| Classification Name: | |
| Classification: | |
| Regulation Number: | |
| Product Code: |
Predicate Devices:
Description:
Intended Use:
Substantial Equivalence:
Intra-Lock® International 6560 West Rogers Circle Boca Raton, FL 33487 (561) 447-8282 (561) 447-8283 Mary L. Jean March 12, 2014 Intra-Lock® Dental Implants Dental Implant Implant, Endosseous, Root-Form Class II 872.3640 DZE
Intra-Lock® Dental Implant System with Blossom, K103194 BioHorizons Internal, Single-Stage and Tapered Implant Systems, K073268, K073282 & K071638
The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.
Intra-Lock® Dental Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
The Intra-Lock® Dental Implants have the same general intended uses, indications, technological characteristics, and principles of operation as the predicate device(s). Both the proposed and predicate implant designs are equivalent; with tapered and straight body and similar size range with equivalent thread designs to meet the varying needs of the dental professionals. The proposed and predicate implant systems have equivalent principals of operation; offering implant design specific drilling sequence in labeling for preparation of the osteotomy.
1
| Technological
Characteristics | Intra-Lock Dental
Implants | Intra-Lock Dental
Implants with BlossomTM
K103194 | BioHorizons Implants
K073268, K073282, K071638 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti6AL4V &
CP Titanium | Ti6AL4V | Ti6AL4V |
| Prosthetic
connection | Internal Connection | Internal Connection | Internal Connection |
| Diameter | 3.75mm, 4.0mm, 4.3mm,
4.75mm & 5.0mm | 3.4mm 4.0mm & 6.0mm | 3.5mm 3.8mm, 4.0mm, 4.6mm,
5.0mm, 5.8mm & 6.0mm |
| Lengths | 8mm - 15mm | 8mm - 15mm | 7.0mm - 15mm |
| Body Design | Straight & Tapered
Tissue and bone level collar | Straight & Tapered | Parallel-wall (straight) & Tapered
Tissue and bone level collar |
| Thread Design | Buttress and Square buttress
thread design with
traditional cutting flutes or
BlossomTM | Buttress thread design with
BlossomTM | Square thread design with
traditional cutting flutes |
| Collar Design | Short (bone level)
Long, 2mm, (tissue level)
with micro-threads | Short (bone level) with
micro-threads | Bone level and tissue level with
Laser-Lok microgrooves |
| Principals of
operation | surgical drilling sequence
provided by Intra-Lock to
create the osteotomy prior
to placement of implant.
Abutment mates with
implant's internal
connection | surgical drilling sequence
provided by Intra-Lock to
create the osteotomy prior to
placement of implant.
Abutment mates with
implant's internal
connection | surgical drilling sequence
provided by Biohorizon to create
the osteotomy prior to placement
of implant. Abutment mates with
implant's internal connection |
Clinical / Non-Clinical Data
No new performance testing was conducted.
Mechanical bench testing of two previously identified Intra-Lock Dental Implant System worst-case scenario (i.e. smallest diameter implant / angled abutments), which remains applicable for the implants contained in this submission and was previously reviewed in K103194, April 21, 2011 and/or K111199, August 8, 2011.
Conclusion:
Based on the data within this submission, the Intra-Lock dental implants are substantially equivalent to the predicate dental implants identified. The minor differences between proposed devices and the predicate devices raise no new issues of safety, risk to health or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol with three curved shapes that resemble a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2014
Intra-Lock International, Incorporated Mary L. Jean Regulatory Affairs Manager 6560 West Rogers Circle, Building #24 Boca Raton, FL 33487
Re: K133613
Trade/Device Name: Intra-Lock® Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 18, 2013 Received: December 26, 2013
Dear Ms. Jean:
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.
3
Page 2 - Ms. Jean:
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 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 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/Resourcesfor You/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/3/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The acronym "DAGRID" is also present. The word "FOR" is at the bottom right.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Intra-Lock® International
Premarket Notification 510(k) - Intra-Lock® Dental Implants
Page 1 of 1
Indications for Use
510(k) Number (if known): K133613
Device Name: Intra-Lock® Dental Implants
Indications for Use:
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
18
: 18026 -04'00"
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