(175 days)
032454
Not Found
No
The summary describes a dental implant with a specific surface technology (Laser-Lok) and its mechanical and biological properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an implant designed for use in edentulous sites for support of dental prostheses and to attach and retain bone and soft tissue, which are actions intended to restore or replace physiological functions, thus qualifying it as a therapeutic device.
No.
The device is an implant designed for supporting dental prostheses, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant with a surface technology, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is a dental implant designed to be placed in the body (in edentulous sites) to support dental prostheses.
- The device description focuses on the physical properties and biological interaction of the implant with tissue and bone. It describes a surface technology and its effects on tissue attachment and bone retention.
- There is no mention of analyzing biological samples or providing diagnostic information. The device's function is structural support and biological integration, not diagnostic testing.
Therefore, this device falls under the category of a medical device, specifically a dental implant, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.
Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.
The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous sites
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)
Mechanical testing was done in accordance with the FDA guidance "Information for premarket notification submissions for screw-lype elidossedus implans" issued on December 9, 1996. Results from an independent lab verify the surface treatment to have sufficient mechanical static and dynamic strength.
Additional test reports include finite element analysis, animal and clinical testing.
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.
032454
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
K04/1136
510(k) Summary
SUBMITTER:
Submitted on behalf of:
| Company Name: | Bio-Lok International Inc. | |
|---|---|---|
| Address: | 368 South Military Trail | |
| Deerfield Beach, FL 33442 | ||
| Telephone: | (954) 698-9998 | |
| Fax: | (954) 698-9925 | |
| by: | Elaine Duncan, M.S.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| PO Box 560 | ||
| Stillwater, MN 55082 | ||
| Telephone: | ||
| Fax: | 715-549-6035 | |
| 715-549-5380 | ||
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | April 27, 2004 | |
| TRADE NAME: | Laser-Lok™ surface treatment for use with Silhouette™ & | |
| Silhouette™ IC dental implant system | ||
| COMMON NAME: | Dental implant, Endosseous |
SUBSTANTIALLY EQUIVALENT TO: Laser-Lok surface treatment is a line extension (optional surface modification) to the Silhouette™ and Silhouette™ IC dental implants. These surface modified implants are substantially equivalent to the predicate the Silhouette™ and Silhouette™ IC dental implants previously cleared under 510(k) # 032454. Additionally, FDA has cleared similar surface treatments for dental implants, such as the surface treatment on the Astra Tech Fixture ST
DESCRIPTION of the DEVICE: Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.
Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.
The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant 3,b
a. Bone Response to Laser Microtextured Surfaces by Ricci, J.L., Charvet, J., Frenkel, S.R., Chang, R., Nadkarni, P., Turner, J., Alexander, H .: Chapter 25 in: Bone Engineering, ed; JE Davies, 2000, Em2 Inc., Toronto (pages 8 & 9).
b. Advanced Surface Microtexturing Techniques to Enhance Bone and Soft Tissue Response to Dental Implants by Weiner, S., Simon, J., Ehrenberg, D.S., Zweig, B., Ricci, J.L.: presented at the Academy of Osseointegration 2003 Annual Meeting, Boston and pending publication in the International Journal of Oral and Maxillofacial Implants.
1
510(k) Summary-Continued
KC4//R6
The Laser-Lok surface treatment on the collar does not reduce the safety and inflammation performance of Silhouette Implants.
INDICATIONS FOR USE: The implant is designed for use in edentulous sites for support of complete INDICATIONS FOR USE. The mipant is designed for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
SUMMARY of TESTING: The Laser-Lok surface treatment does not introduce new issues for SUMMANY of TECTERS of TECH in a summary of all testing conducted to-date.
Mechanical testing was done in accordance with the FDA guidance "Information for premarket notification Mcchanical (c.sting was done in accerdaims) ants" issued on December 9, 1996. Results from an submissions for screw-lype elidossedus implans "Issued on Decombor "1999 of the surface treatment to have sufficient mechanical static and dynamic strength.
Additional test reports include finite element analysis, animal and clinical testing.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Bio-Lok International, Incorporated C/O Ms. Elaine Duncan President Paladin Medial, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560
Re: K041136
Trade/Device Name: Laser-Lok Surface Treatment for Silhouette™ and Silhouette™ IC Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 10, 2004 Received: August 11, 2004
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your was 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to activend Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin upprivation (the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 Mr), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in the lev announcements concerning your device in the Federal Register.
3
Page 2 – Ms. Duncan
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualice of a substance on ples with other requirements
mean that FDA has made a determination that your device complies with other popular mean that FDA has made a decemination that Journinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by perstreating of the Act of ally rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing proctice You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); group 800'; and i and listing (21 CFR Fart 807), labeling (21 CFR al results) //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set forth in the quality systems (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) This letter will anow you to begin maticoling your and equivalence of your device to a premarket notification. The FDA miding of basical on 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), a if you desire specific advice for your do roll and and and the regulation please contact the Office of Comphanes at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on Jour Land Consumer Assistance at its toll-free Division of Binastic or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, 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):
Device Name: Laser-Lok surface treatment for Silhouette™ and Silhouette™ IC endosseous implant
Indications for Use:
The implant is designed for use in edentulous sites for support of complete denture The implant is designed for use in coonarous of to fixed bridgework or partial dentures,
prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentu prosulesis, a terminal or ment, overdenture, or hybrid denture.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearson
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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