(261 days)
Not Found
No
The summary describes a physical dental implant system and associated tools, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The NaturaLLock implant system is indicated for the support and retention of fixed single tooth and fixed partial denture restorations, which serves a restorative and supportive function rather than a direct therapeutic one.
No
The device is described as an implant system for supporting and retaining dental restorations, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states that the NaturaLLock implant system includes physical components such as implants, dental tools, instruments, drills, drill guide sleeves, and a surgical tray. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The NaturaLLock implant system is a physical implant made of titanium that is surgically placed into the jawbone. It is used to support dental restorations.
- Intended Use: The intended use is for the support and retention of dental restorations in the mouth. This is a surgical and prosthetic procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The NaturaLLock implant system is a medical device used for surgical and restorative purposes in dentistry.
N/A
Intended Use / Indications for Use
The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The NaturaLLock single-stage implant for immediate restoration combines the endosteal and prosthetic implant sections in one piece (integrated abutment). The anatomically shaped implant has a self-tapping thread.
The NaturaLLock implant system includes single-stage implants, dental tools, instruments, drills, drill guide sleeves and a surgical tray, which contains a complete set of instruments structured according to the logical sequences of surgery.
The system is colour coded as follows: red Ø 3.5 mm, yellow Ø 4.3 mm, blue Ø 5.0 mm, green Ø 6.0 mm. The instruments are laser marked with the following information: drills: Ø and length, implant driver: Ø
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
molar, premolar, cuspid, and incisor regions of partially edentulous jaws; anterior mandibular arch; upper and lower jaw.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only - qualified dental implantologists, oral surgeons or maxilla surgeons only. Strictly reserved to specialised and trained users. Dental practises
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)
Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that ZL Microdent NaturaLLock implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. A series of safety and performance testing were performed to demonstrate that the ZL Microdent NaturaLLock implants do not raise any new issues of safety and efficacy.
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.
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
Image /page/0/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 three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust21, 2014
ZL Microdent Attachment GmbH Synnöve Lindeman Head of Quality Management Schutzenstrabe 6-8 Breckerfeld, DE D-58339
Re: K132585
Trade/Device Name: ZL Microdent Natural Lock Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseus Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 21, 2014 Received: July 24, 2014
Dear Ms. Lindeman:
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.
1
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 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.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indication for Use
510(k) Number:
Device Name: ZL Microdent NaturaLLock Implant System
Indications for use:
The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The implants are offered in sterile condition, all other components can be sterilized in an autoclave .
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Page 01 of 01
3
Summary
4
510(k) Summary as required by section 807.92(c)
K-number: K133706
Submission Applicant:
ZL Microdent-Attachment GmbH & Co. KG Schützenstraße 6-8 58339 Breckerfeld Germany
Phone: +49 (0)2338-801-0 Fax: +49 (0)2338-801-40 E-mail: Synnoeve.lindeman@zl-microdent.de
Establishment Registration Number:
3008134186
Application correspondent/Contact person:
Synnöve Lindeman Schützenstrasse 6-8 D-58339 Breckerfeld, Germany
Phone: +49 (0)2338 80143 Fax: +49 (0)2338 80140 E-mail: synnoeve.lindeman@zl-microdent.de
Trade name:
ZL Microdent NaturaLLock Implant System
Common name:
One-piece implant system
5
Classification name:
Endosseous dental implant, Dental (21 CFR 872.3640- DZE)
Predicate devices:
K031345 Nobel Direct
Nobel Biocare USA Inc., 22715 Savi Ranch Parkway, Yorba Linda, CA 92887, USA
K062281 Zimmer One Piece, 4,7mm
K052997 Zimmer Once Piece
Zimmer Dental Inc., 1900 Aston Ave., Carlsbad, CA 92008, USA
6
Substantial Equivalence Comparison Table
| Relevant Areas | ZL Microdent -
NaturaLLock implant system | Result | Nobel Biocare USA -
Nobel Direct implant system | Zimmer Dental Inc. -
One piece implant system |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Indications for use | The NaturaLLock implant system is an
endosseous dental implant system made of
titanium. NaturaLLock implants are indicated
for the support and retention of fixed single
tooth and fixed partial denture restorations in
the molar, premolar, cuspid, and incisor
regions of partially edentulous jaws.
NaturaLLock implants may be loaded
immediately in the anterior mandibular arch if
four are splinted together with a bar.
NaturaLLock implants may be immediately
restored with a temporary prosthesis that is
not in functional occlusion. | s.e. | The Nobel Biocare - Nobel Direct implant
system is an endosseous dental implant system
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. | The Zimmer) Dental One-Piece Implant is a
one-piece endosseous dental
implant which is a combination of implant and
abutment sections. The
implant is composed of titanium alloy. The
abutment portion is pre-prepared
and contoured for esthetic restoration. The
abutment portion of the implant
features a pre-prepared margin to facilitate the
restoration process. The
implant section is designed for ease of
implantation and with greater surface
area for osseointegration. The implant section
surface is treated to facilitate
osseointegration. In addition, the implant
section is tapered with either double
or triple-lead threads, depending upon the
apical diameter. |
| Material | ZL Microdent NaturaLLock implants are
made of Titanium | s.e. | Identical | Identical |
| Target population | Professional use only - qualified dental
implantologists, oral surgeons or maxilla
surgeons only. Strictly reserved to specialised
and trained users. | s.e. | Identical | Identical |
| Where used | Dental practises | s.e. | Identical | Identical |
| Packaging | The NaturaLLock implant packaging
comprises a non-sterile storage packaging
with instructions for use (paper), a secondary
packaging as a germ barrier and implant
holding unit (glass) and a sterile primary
packaging (glass)
The glass container is delivered with a sticker
showing all relevant information. Furthermore
the storage packaging includes a sandwich tag
for transference to the patient file (LOT No.) | s.e. | Similar | Similar |
| Relevant Areas | ZL Microdent –
NaturaLLock implant system | Result | Nobel Biocare USA –
Nobel Direct implant system | Zimmer Dental Inc. –
One piece implant system |
| Performance /
Biocompatibility | Testing according ISO 10993 Biological
Evaluation of Medical Devices applying all
relevant provisions for the devices.
All relevant testing regarding biocompatibility
was carried out by ZL Micodent-Attachment
GmbH & Co. KG with a total compliance
with the provisions of ISO 10993.
The same material is used for the predicate
devices manufactured and distributed by
Nobel Biocare USA and Leader Italia, which
received market clearance and are in
commercial distribution. | s.e. | Identical | Identical |
| Sterilization | All implants are sold sterile. Drills,
instruments and other invasive components
are sold non sterile and need to be sterilized
according to the manufacturers validated
processing instructions. All components and
instruments need to be sterilized prior to use. | s.e. | Identical | Identical |
| Sizes & Diameters | ZL Microdent NaturaLLock implants and its
components are available in the following
lengths and diameters:
Diameters & lengths:
Ø 3.5 – lengths: 10, 13 & 16mm
Ø 4.3 – lengths: 8, 10, 13 & 16mm
Ø 5.0 – lengths: 8, 10, 13 & 16mm
Ø 6.0 – lengths: 8, 10, 13 & 16mm | s.e. | Nobel Biocare Nobel Direct implants and its
components are available in the following
lengths and diameters:
Diameter:
Ø 3.0, 3.5, 4.3, 5.0 and 6.0mm
Length:
8, 10, 13 and 16mm | Zimmer Once Piece Implants and its
components are available in the following
lengths and diameters:
Diameter:
Ø 3.0, 3.7 & 4.7mm
Length:
10, 11.5, 13 and 16mm |
7
8
Description of the device:
The NaturaLLock single-stage implant for immediate restoration combines the endosteal and prosthetic implant sections in one piece (integrated abutment). The anatomically shaped implant has a self-tapping thread.
The NaturaLLock implant system includes single-stage implants, dental tools, instruments, drills, drill guide sleeves and a surgical tray, which contains a complete set of instruments structured according to the logical sequences of surgery.
The system is colour coded as follows: red Ø 3.5 mm, yellow Ø 4.3 mm, blue Ø 5.0 mm, green Ø 6.0 mm. The instruments are laser marked with the following information: drills: Ø and length, implant driver: Ø
Indication range:
For single and multiple tooth replacement in the upper and lower jaw. Adequate bone quality, width and height must be available. It has to be proven carefully, if the systemic state of the patient is adequate for an implantation, and especially if there are any allergic reactions on the implant components as well as any prohibitive diseases (e.g. diabetes, smoker).
Indications for Use:
The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Comparison with predicate devices:
The ZL Microdent product is similiar to the predicate devices in terms of technical characteristics, design, indications for use, target population, where it is used, performance, biocompatibility characteristics as well as sizes, surfaces and configurations. Similar as the Nobel and Zimmer predicate devices the ZL Microdent NaturaLLock implants are one-piece constructions, have an integral, pre-contoured abutment, a tapered implant body, a self-cutting thread and an implant head with symmetrical, axially directed grooves.
9
Conclusion: The ZL Microdent product can be deemed substantially equivalent for its indicated use.
Summary of the non-clinical testing data:
Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that ZL Microdent NaturaLLock implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. A series of safety and performance testing were performed to demonstrate that the ZL Microdent NaturaLLock implants do not raise any new issues of safety and efficacy.
Summary:
The presented data that was conducted on the ZL Microdent products, shows in its results and in comparison to the predicate devices substantially equivalence to the predicate devices for their intended use. The used materials are well researched.