(174 days)
The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single 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 Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Intra-Lock Dental Implant System with Blossom." It describes a dental implant system and presents information to demonstrate its substantial equivalence to previously marketed predicate devices.
Based on the provided text, the device itself is a dental implant, not an AI/ML powered device, therefore no information regarding AI/ML powered device acceptance criteria, study design or performance is available.
The relevant "Testing" section states: "Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device."
Therefore, the only acceptance criteria and study data provided relate to the physical properties of the dental implant, specifically its fatigue properties.
Here's the breakdown of the information that can be extracted, and where AI/ML related information is explicitly not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (related to fatigue) | Reported Device Performance (related to fatigue) |
|---|---|
| Fatigue properties of the new design did not change from the predicate. | The fatigue properties of the new design are similar to those of the predicate device (K021322 Intra-Lock). The fatigue test was successful according to ISO 14801. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the fatigue testing. (e.g., how many implants were tested, how many cycles).
- Data Provenance: The standard used for testing is ISO 14801, an international standard. No information regarding country of origin of the data or whether it was retrospective or prospective is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the "ground truth" for a mechanical fatigue test is determined by the physical failure of the device, not expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as there is no human adjudication involved in a mechanical fatigue test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable as the device is a physical dental implant, not an AI/ML powered device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the fatigue test is the physical failure or successful endurance of the dental implant under specific cyclic loading conditions, as defined by the ISO 14801 standard. This is a mechanical performance ground truth.
8. The sample size for the training set
- This question is not applicable as there is no mention of an AI/ML model and therefore no "training set."
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of an AI/ML model and therefore no "training set" ground truth.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
March 7, 2011
APR 2 1 2011
Submitted by: Jeff Sakoff
Address: Intra-Lock International 6560 West Rogers Circle Boca Raton, FL 33487
Telephone: 561-447-8282 561-447-8283 Fax:
Classification Name: Endosseous Dental Implant 21 CFR 872.3640
Trade Name: Intra-Lock Dental Implant System with Blossom
Legally Marketed Device: K021322 Intra-Lock Dental Implant System, K063341 Certain dental implants and K072363 Nanotite dental implants
Device Description: The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.
Indications for Use: The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction. They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
Substantial Equivalence:
| This device. | K021322 intra-Lock | K072363 Certain | K063341 Certain | |
|---|---|---|---|---|
| Design | Internal six-splinetaperlockconnectionwith smaller | Internal six-splinetaperlockconnection | Internal 12 pointhex connection withsmaller threading atthe top | Internal 12 pointhex connectionwith smallerthreading at the top |
| threading at the top | ||||
| Sizes | 3.4, 4.0, 4.0conic, 6.0 | 3.5,3.75,4.0 | 3.25,3.75,4.0,5.0,6.0 | 3.25,3.75,4.0,5.0,6.0 |
| Material | Ti 6AL4V | CP Ti | Ti6Al4V | Ti6AL4V |
| Indication | The Intra-LockDental ImplantSystem hasbeen designedto restorepartially orfullyedentulouspatients. Theimplants havebeen designedto be used ineither themandible orthe maxillaand to supportremovable orfixedprosthesis,from singletoothreplacementto full archreconstruction.They areintended forimmediatefunction onsingle and/ormultiple toothapplicationswhen goodprimarystability isachieved, withappropriateocclusalloading, inorder torestore normalteethfunctions. | The Intra-LockImplantSystem hasbeen designedto restorepartially orfullyedentulouspatients. Theimplants havebeen designedto be used ineither themandible orthe maxillaand to supprtremovable orfixedprosthesis,from singletoothereplacementto full archreconstruction. | Intended forsurgical placementin the upper orlower jaw toprovide the meansfor prostheticattachment in singletooth restorationsand in partially orfully edentulousspans with multiplesingle teeth utilizinga delayed orimmediate loadingor as a terminal orintermediaryabutment for fixedor removablebridgework, and toretainoverdentures.Intended forimmediate functionon single toothand/or multipletooth applicationswhen good primarystabiliy is achieved,with appropriateocclusal labeling, inorder to restorechewing function. | Intended forsurgical placementin the upper orlower jaw toprovide means for aprosthesisattachment in singletooth restorationsand in partially orfully edentulousspans with multiplesingle teeth, or as aterminal orintermediaryabutment for fixedor removablebridgework, and toretainoverdentures. Inaddition, when aminimum of 4implants,≥10mm inlength, are placed inthe mandible andsplinted in theanterior region,immediate loadingis indicated. |
| Cutting | Blossom | fluted | fluted | fluted |
| Design | ||||
| TestingResults | ISO 14801fatigue testsuccessful | ISO 14801fatigue testsuccessful | Unknown, not in510k summary | Unknown, not in510k summary |
{1}------------------------------------------------
{2}------------------------------------------------
Testing: Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device.
Substantial Equivalence: The Intra-lock dental implants with Blossom are updated versions of the Intralock dental implants. The design, materials, instructions for use and packaging are the same. The indications for use is a combination of the indications for K021322 and K072363. Some of the design changes made to the threading are similar to threading in K063341. Fatigue testing showed this new version of the Intra-lock dental implants with Blossom threads has very similar fatigue properties to the previous version of Intra-lock dental implants.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intra-Lock International, Incorporated C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 6560 West Rogers Circle Boca Raton, Florida 33487
APR 2 1 2011
Re: K103194
Trade/Device Name: Intra-Lock Dental Implant System with Blossom Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 15, 2011 Received: April 18, 2011
Dear Ms. Blackwell:
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.
{4}------------------------------------------------
Page 2- Ms. Blackwell
Please be advised that I'DA'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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K | 03194
Device Name: Intra-Lock Dental Implant System with Blossom
Indications for Use:
· The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSbetz DDS for Dr. S. Renner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103194
Page of of ___________________________________________________________________________________________________________________________________________________________________
§ 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.