(191 days)
Not Found
No
The summary describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a dental implant intended for restoring teeth function and stabilizing dentures, which is a restorative device rather than a therapeutic one designed to treat a disease or condition.
No
This device, the Intra-Lock® OP Dental Implant, is a medical implant designed to restore teeth function by serving as a replacement for missing teeth. Its purpose is to physically support prostheses and restore normal function, not to diagnose a medical condition or disease.
No
The device description clearly states it is a threaded dental implant, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a dental implant, which is a surgically implanted device used to replace missing teeth and support prostheses. It is a physical device placed within the body, not a tool for analyzing biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic tests performed on samples.
Therefore, based on the provided information, the Intra-Lock® OP Dental Implant is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.
3.75mm, 4.0mm and 4.75mm Intra-Lock® OP Dental Implants: 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 tecth functions.
Product codes
DZE
Device Description
The Intra-Lock® OP Dental Implants are threaded dental implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with an integrated straight abutment (implant and abutment arc one piece).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular tissue, single or maxillary lateral incisors and mandibular lateral and central incisors, 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
The following was reviewed to support performance of the Intra-Lock® OP Dental Implants for their intended use: risk analysis, shelf life and sterilization validation, surface analysis and static / dynamic fatigue.
Key Metrics
Not Found
Predicate Device(s)
K052997 & K062281 Zimmer® One-Piece Implant, K050970, MILO® Implant System, K103194, Intra-Lock® Implant System with Blossom™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
AUG
| Submitter's Name: | Intra-Lock® International
6560 West Rogers Circle
Boca Raton, FL 33487 | | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | (561) 447-8282 | | | |
| Facsimile: | (561) 447-8283 | | | |
| Contact Person: | Diana Taylor | | | |
| Date Prepared: | July 30, 2013 | | | |
| Name of Device: | Intra-Lock® OP Dental Implants | | | |
| Common Name: | Dental Implant | | | |
| Classification Name: | Implant, Endosseous, Root-Form | | | |
| Classification: | Class II | | | |
| Regulation Number: | 872.3640 | | | |
| Product Code: | DZE | | | |
| Predicate Devices: | K052997 & K062281 Zimmer® One-Piece Implant
K050970, MILO® Implant System,
K103194, Intra-Lock® Implant System with Blossom™ | | | |
| Description | The Intra-Lock® OP Dental Implants are threaded dental
implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with
an integrated straight abutment (implant and abutment arc one
piece). | | | |
| Intended Use: | The 3.0mm Intra-Lock® OP Dental Implants are indicated for
long-term maxillary and mandibular tissue-supported denture
stabilization. They are also indicated for the rehabilitation of
single or maxillary lateral incisors and mandibular lateral and
central incisors. Multiple implants may be restored after a
period of delayed loading or placed in immediate function
when good primary stability is achieved with appropriate
occlusal loading in order to restore normal teeth function. | | | |
| | 3.75mm, 4.0mm and 4.75mm Intra-Lock® OP Dental Implants:
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 tecth
functions. | | | |
| Performance Testing: | The following was reviewed to support performance of the
Intra-Lock® OP Dental Implants for their intended use: risk
analysis, shelf life and sterilization validation, surface analysis
and static / dynamic fatigue. | | | |
| | Proposed OP Implants
3.0mm 3.75mm, 4.0mm & 4.75mm | Zimmer & One-Piece,
K052997 - 3.0mm & 3.7mm
K062201 - 4.7mm | Intra-Lock MILO® 3.0mm
Implants, K050970 | Intra-Lock® Dental Implant
System with Blossom™,
K103194 |
| Material | TI6AL4V, CP Titanium | Titanium Alloy | TI6AL4V | TI6AL4V, CP Titanium |
| Surface | Blasted | Zimmer MTX Surface | Blasted | Blasted |
| Thread
Patterns | - 3.0mm, wide pitch, no cutting flutes
- 3.75mm wide pitch w/ cutting flutes
- 4.0mm & 4.75mm Blossom
All designs feature horizontal micro threads | cutting flute on the apical end no horizontal
micro threads | Wide pitch, no cutting flutes,
horizontal micro threads | Blossom - at least one cutting
surface on each thread and
horizontal micro threads. |
| Design sizes | 3.0mm.3.75mm 4.0mm& 4.75mm dia;
10mm - 15mm lengths | 3.0mm dia, 10-13mm lengths
3.7mm & 4.7mm dia ; 10 - 16mm lengths | 3.0mm, O-Ball implant
10mm - 15mm lengths | 3.5mm, 4.0mm (& 6.0mm) dia;
8mm - 15mm lengths |
| Abutment | Straight abutment machined on implant | Straight abutment machined on implant | Abutments cemented | Screw retained abutments via
internal connection |
| Principals of
Operation | Machined abutment has mating features so
the design specific driver fits directly over
the abutment for pick up, delivery
(placement) and final seating.
The OP transfer is snapped over the
abutment to be picked up in the impression.
The OP analog is inserted into the transfer
prior to creating the working model. | Instrumentation engage the implant
externally to pick up deliver and seat the
implant.
The impression cap snaps over the abutment
and picked up in the impression.
The analog replicates the Zimmer One-Piece
Implant in the stone model. | Instrumentation fits over the
O-Ball for pick up, delivery
and final seating.
MILO impression coping
snaps over the O-Ball to be
picked up in the impression.
The MILO analog is inserted
into the transfer prior to
creating working model | Instrumentation pick up the
Blossom implant via hex
configuration which mates with
the internal connection of the
implant.
A screw retains the impression
coping. Analogs are placed in
the transfer and secured with
screw. |
| Intended use | The 3.0mm Intra-Lock® OP Dental Implants
are indicated for long-term maxillary and
mandibular tissue-supported denture
stabilization. They are also indicated for the
rehabilitation of single or maxillary lateral
incisors and mandibular lateral and central
incisors. Multiple implants may be restored
after a period of delayed loading or placed in
immediate function when good primary
stability is achieved with appropriate
occlusal loading in order to restore normal
teeth function.
3.75mm 4.0mm and 4.75mm;
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. | Zimmer One-Piece 3.0mm implants are
indicated for the support and retention of
fixed single tooth and fixed partial denture
restorations in the mandibular central and
lateral incisor and maxillary lateral incisor
regions of partially edentulous jaws. The
Zimmer one piece 3.0mm implant must be
splinted if two or more are used adjacent to
each other. The Zimmer One Piece 3.0mm
implant may be immediately restored with a
temporary prosthesis that is not in functional
occlusion.
Zimmer One-Piece 3.7mm & 4.7mm implants
are indicated for the support and retention of
fixed single tooth and fixed partial denture
restoration in the premolar, cuspid and
incisor regions of partially edentulous jaws.
Zimmer one-piece implants may be loaded
immediately in the anterior mandibular arch
if four are splinted together with a bar. The
Zimmer one-piece implant may be
immediately restored with a temporary
prosthesis that is not in functional occlusion. | MILO® Dental Implants are
indicated for long-term
maxillary and mandibular
tissue supported
denture stabilization. They
are also indicated for the
rehabilitation of single or
maxillary lateral incisors and
mandibular lateral and
central incisors. Multiple
implants may be restored
after a period of time or
placed in immediate function. | 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. |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Shelf Life | 5 years | 5 years | 5 years | 5 years |
:
1
Substantial Equivalence:
The Intra-Lock® Op Implant and Zimmer® One-Picce Implants both have machined abutments that include design features to mate with instrumentation and utilize the same principals of operation. All the predicates have the same or similar matcrials, intended use, indications, sterilization and shelf life as the Intra-Lock® OP Implants. The substantial equivalence summary table follows:
Conclusion:
The comparison confirms that the Intra-Lock® OP Implants are substantially equivalent to the predicate devices. The minor differences between these designs and principals of operation raise no new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
August 1, 2013
Intra-Lock® International, Incorporated Ms. Diana Taylor Regulatory Affairs Manager 6560 West Rogers Circle, #24 Boca Raton, FL 33487
Re: K130140
Trade/Device Name: Intra-Lock® OP Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 28, 2013 Received: July 1, 2013
Dear Ms. Taylor:
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. Taylor
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 devicerelated 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/ResourcesforYou/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/ReportalProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Indications for Use
510(k) Number (if known): _K | 30/YO
Device Name: Intra-Lock® OP Dental Implants
Indications for Use:
For 3.0mm Intra-Lock® OP Dental Implants:
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.
For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants:
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either 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 U
(21 CFR 801 Subpa
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)
Andrew I. Steen -S 2013.08.01 10:39:02 -04'00'
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
1150/40 510(k) Number:________________________________________________________________________________________________________________________________________________________________