(360 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an implant for treating oral endosteal implantation and rehabilitating edentulous and partially dentate patients, indicating its medical and therapeutic purpose.
No
The device description clearly states its purpose as a dental implant system for oral endosteal implantation and rehabilitation. It is designed to replace missing teeth and restore chewing function, not to diagnose a disease or condition.
No
The device description explicitly states it is a dental implant system consisting of threaded, root-form endosseous implants and corresponding abutments made of Titanium and POM-C, which are hardware components.
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 for surgical implantation into the jaw for the functional and esthetic rehabilitation of patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium and abutments, designed to be surgically placed and integrated with bone. This aligns with a medical device for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect biomarkers, or provide information for diagnosis.
- Performance Studies: The performance studies focus on bench testing related to mechanical performance, osseointegration, and sterilization – all relevant to a surgically implanted device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.
Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.
Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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)
The proposed device has been subject to bench testing to determine conformance to performance rne proposed arrive has book taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff – Class II following and includine of Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Functional laboratory testing performed in foreseable operating conditions showed correct operation r anotice as per its intended use, specifically including mechanical performance when subject to of the dones as per no menility and biological testing in accordance with the level and duration of contact with the human body, surface finish evaluation including chemical analyses, and sterilization process validation.
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.
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
|K09226|
JUL 2 8 2010
| DATE OF PREPARATION: | 2010-07-15 |
|---|---|
| SUBMITTER NAME: | Impladent, S.L. |
| SUBMITTER ADDRESS: | Pol. Ind. Mas d'en Cisa |
| C/ Gato Perez 3-9 | |
| 08181 SENTMENAT, BARCELONA, SPAIN |
CONTACT: TELEPHONE: Fax: e-mail:
08181 SENTMENAT, BARCELONA, SF José Ramón Gutiérrez + 34 902 20 14 13 + 34 902 25 92 60
IMPLADENT DEFCON TSA / TSH Dental Implant Systems DEVICE TRADE NAME: Root-form Endosseous Dental Implant COMMON NAME: Root-form Endosseous Dental Implant (21 CFR 872.3640) CLASSIFICATION NAME:
| - NobelActive 8.5 mm & 18.0 mm – Nobel Biocare (K083205)
- NobelActive Internal Connection Implant - Nobel Biocare (K071370) | PREDICATE DEVICE(S): | - Straumann Dental Implant System – Straumann Institut (K083550)
- ITI Dental Implant System - Straumann Institut (K033984)
- Various Branemark System Dental Implant Products - Nobel Biocare (K022562) | |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF
COMPARISON
WITH
PREDICATE
DEVICE: | PROPOSED DEVICES | PREDICATE DEVICES | |
| Implant
Material
Form / Features | DEFCON TSA / TSH Implant System
Commercially Pure Titanium Grade 2
Root-form cylindrical-conical, Threaded,
Hexagonal & conical Internal connection (TSA)
Hexagonal External connection (TSH) | for TSA
K071370 NobelActive Internal Connection Implant
K083205 NobelActive 8.5mm & 18.0mm
K083550 Straumann Dental Implant System
K033984 ITI Dental Implant System
Commercially Pure Titanium Grade 4
Root-form cylindrical-conical, Threaded,
Hexagonal or Octagonal & conical Internal connection | for TSH
K022562 Various Branemark System Dental
Implant Products
Commercially Pure Titanium Grade 1
Root-form cylindrical-conical, Threaded,
Hexagonal External connection |
| Range of diameters | $Ø$ prosthetic connection: 3.36.05.5 | $Ø$ prosthetic connection: 3.5
$Ø$ endosseous: 3.36.55.0 | $Ø$ prosthetic connection: 3.5
$Ø$ endosseous: 3.35.15.0 |
$Ø$ endosseous: 3.3
| Range of lengths | 8.516.0 | 6.0-18.0 | 7.0-18.0 |6.0
| Surface Treatment | Grit-blasted, acid etched -to increase TiO2
superficial layer | Electrochemical oxidation process or sand-blasting and
acid etching to increase TiO2 superficial layer. | Electrochemical oxidation process to increase
TiO2 superficial layer |
| Healing Caps, Screw and Cement Retained Abutments
Material
Form / Features | Titanium Grade 5 (TIAI6V4 ELI)
Cylindrical, taper and hexagonal connection (TSA
internal; TSH external). Tapered external shape. | Titanium
Cylindrical, taper and hexagonal or octagonal internal
connection. Tapered external shape. | Titanium
Cylindrical, taper and external hexagonal
connection. Tapered external shape. |
| Range of diameters | $Ø$ prosthetic connection: 3.3
Abutment diameter: 4.26.9 | $Ø$ prosthetic connection: 3.56.5
Abutment Diameter: 3.65.0 | $Ø$ prosthetic connection: 3.05.1
Abutment Diameter: 4.06.0 |7.0 | 1.5
| Range of lengths | 0.57.0 | 1.57.0 |
| Temporary Caps (only available in DEFCON TSA system)
Material
Form / Features | POM coping, Titanium Grade 5 (TiAl6V4 ELI)
Conical and post shape. Screw retained. Internal
connection. Anatomic emergence for gingival
conformation. | POM coping, Titanium abutment or Polyether ether
ketone + Ti.
Conical and post shape. Internal connection. Screw
retained. Anatomic emergence for gingival conformation. | Not applicable |
| Range of diameters | $Ø$ prosthetic connection: 3.76.0 | $Ø$ prosthetic connection: 3.56.5 | |
| Range of lengths | 1.5 transmucosal height | 1.53.0 transmucosal height | |4.7 | $Ø$ prosthetic connection: 3.5
| Retentive Anchors for Over dentures
Material
Form / Features | Titanium Grade 5(TiAI6V4 ELI), EPDM
Ball abutment plus o-ring titanium cap. | Titanium, gold
Abutment plus adjustable retention anchor. | Titanium, rubber
Ball abutment plus o-ring plastic cap. |
| Range of diameters | $Ø$ prosthetic connection: 3.76.5 | $Ø$ prosthetic connection: 3.54.1 |
| Range of lengths | 1.05.0 transmucosal height | 1.06.0 transmucosal height | 1.0~10.0 |
DEVICE DESCRIPTION:
DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.
Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.
1
ECTION 5 : 510(k) SUMMARY Impladeni
Range on many (dimensions in mm)
. P
2
Image /page/2/Picture/0 description: The image shows a document with the title "TECHNICAL EVALUATION DOCUMENTATION". The document also includes the logo for "Impladenit" and the text "Defcon TSA TSH Dental Implant Systems". The document is labeled as "SECTION 5 : 510(k) SUMMARY".
INDICATIONS FOR USE:
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. rover jaw and for the lot single-stage or two-stage surgical procedures and cement or screw retained restorations.
relations. miplance the line is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.
Specific indications for small diameter (Ø3.3 mm) implants:
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
NON-CLINICAL TEST SUMMARY
The proposed device has been subject to bench testing to determine conformance to performance rne proposed arrive has book taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff – Class II following and includine of Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Functional laboratory testing performed in foreseable operating conditions showed correct operation r anotice as per its intended use, specifically including mechanical performance when subject to of the dones as per no menility and biological testing in accordance with the level and duration of contact with the human body, surface finish evaluation including chemical analyses, and sterilization process validation.
CLINICAL TEST SUMMARY
No clinical studies are submitted.
CONCLUSIONS:
We believe the intended use, the indications for use and performance of both the proposed IMPLADENT DEFCON TSA/TSH dental implant systems and the predicate dental implant systems are essentially the same.
We conclude that the proposed DEFCON TSA/TSH dental implant systems are safe and effective for its intended use, and based on the information included in this submission, we believe that substantial equivalence of the proposed device with the legally marketed predicate devices may be established.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jose-Ramon Gutierrez Quality Manager Impladent, S.L. Pol. Ind. Mas D'en Cisa C/ Gato Perez 3-9 Sentmenat, Barcelona Spain 08181
JUL 2 8 2010
Re: K092261
Trade/Device Name: IMPLADENT DEFCON TSA/TSH Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 15, 2010 Received: July 21, 2010
Dear Mr. Gutierrez:
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- Mr. Gutierrez
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 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.
Anthony O. Austen
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
Image /page/5/Picture/0 description: The image contains the logos and titles of a technical document. The logo "Impladent" is on the left side of the image. The title of the document is "TECHNICAL EVALUATION DOCUMENTATION", and the subtitle is "SECTION 04 - INDICATIONS FOR USE STATEMENT". The document is related to Defcon TSA TSH Dental Implant Systems.
Indications for Use
K092261 510(k) Number (if known):
IMPLADENT DEFCON TSA/TSH DENTAL IMPLANT SYSTEM Device Name:
Indications for Use:
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.
Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a
low mechanical load. Placement in the molar region is not recommended.
Prescription Use ✓ (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)
Re: Mulvey for MSP
vision Sign-Off)
vision of Anesthesiology, General Hospital tection Control, Dental Devices
Page 1 of 1
(k) Number: K 09 2261