(300 days)
K 070601, K023705
Not Found
No
The summary describes a physical dental implant and its materials, dimensions, and intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device provides provisional prosthetic support and protects permanent implants during healing, which directly addresses a health condition (edentulous sites) and supports the healing process.
No
Explanation: The device, a transitional implant, is designed for temporary support of prosthetic devices during healing, not for diagnosing medical conditions. It functions as a physical support structure.
No
The device description explicitly states it is a physical implant made of titanium alloy, designed to be surgically placed. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "transitional implant" designed to be surgically placed in the mouth ("edentulous sites") to support dental prosthetics. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for temporary support of dental prosthetics during the healing period of permanent implants, and for other dental applications within the mouth. This is a therapeutic and structural function, not a diagnostic one.
The device is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Transitional Implants are designed for temporary use in edentulous sites. The primary purpose is to provide provisional prosthetic devices to protect the permanent implants from premature loading during the healing period. They are used to support bridges and dentures.
Additional uses are inter-radicular transitional applications, immediate splinting stability, full and partial edentulism and using minimally invasive surgical interventions.
The target population is determined when there is inadequate bone for wider implants as well as for patients wishing immediate functional loading. The transitionals are to be used in a clinical site by a qualified dentist experienced in placing dental implants.
Product codes
DZE
Device Description
This transitional implant is designed to serve as a provisional artificial root to provide immediate load support for permanent implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4 % vanadium for strength. The implants are grit blasted . The diameter is 2.5mm and the Lengths are 10mm,(SM3002, 13mm (SM3003) and 15 mm (SM3004). The implants are designed as one piece with a ball abutment on one end at the top of the implant. The ball fits into a rubber o-ring and keeper in the prosthesis which is designed for retention.
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
a qualified dentist experienced in placing dental implants.
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)
Simpler transitional implants do not introduce new issues for testing from other Simpler implants for materials, surface treatment, fatigue testing and sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mini Drive-Lock Implant K 070601, Bicon K023705
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
673645
510(K)SUMMARY
OCT 2 1 2008
| SUBMITTER: | |
|---|---|
| Submitted on behalf of: | |
| Company Address: | 659543BC Ltd. |
| Simpler One Stop | |
| #404 1023 Wolfe Ave. | |
| Vancouver, BC | |
| V6H 1V6 | |
| By: | Dr. Harold Bergman |
| 604 736 9890 (Telephone) | |
| 604 736 9747 (Fax) | |
| CONTACT PERSON: | Dr. Harold Bergman |
| 604 736 9890 | |
| DATE PREPARED: | Oct. 9, 2008 |
| TRADE NAME: | Simpler Mini Implants |
| COMMON NAME | Narrow Diameter Implants |
| CLASSIFICATION | Class II (Special Controls) |
| CLASSIFICATION NAME: | Endosseous Dental Implant |
The legally marketed devices to which we are claiming equivalence (21 CFR 807.92 (a)(3) are:
Mini Drive-Lock Implant K 070601 Bicon K023705
DESCRIPTION OF THE DEVICE: This transitional implant is designed to serve as a provisional artificial root to provide immediate load support for permanent implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4 % vanadium for strength. The implants are grit blasted . The diameter is 2.5mm and the Lengths are 10mm,(SM3002, 13mm (SM3003) and 15 mm (SM3004).
1
The implants are designed as one piece with a ball abutment on one end at the top of the implant. The ball fits into a rubber o-ring and keeper in the prosthesis which is designed for retention.
INDICATIONS FOR USE: The transitional implant is designed for temportary use in endentulous sites. The primary purpose is to provide provisional prosthetic device protection from premature loading during the healing period. They are used to support bridges and dentures. Additional uses are inter-radicular transitional applications, immediate splinting stability for full and partial edenturlism and using minimally invasive surgical interventions.
The target population is determined when there is inadequate bone for wider implants as well as for patients wishing immediate functional loading. The transitionals are to be used in a clinical site by a qualified dentist experienced in placing dental implants.
SUMMARY OF TESTING: Simpler transitional implants do not introduce new issues for testing from other Simpler implants for materials, surface treatment, fatigue testing and sterilization.
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 stylized caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Harold Bergman 659543BC Limited #404, 1023 Wolfe Avenue Vancouver. BC CANADA V6H 1V6
OCT 2 1 2008
Re: K073645
Trade/Device Name: Simpler Mini Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 10, 2008 Received: October 14, 2008
Dear Dr. Bergman:
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.
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 vour 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 - Dr. Bergman
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uning Chiu S. Lin, Ph. D Division 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): K0736 45
Simpler Mini Dental Implants Device Name:
Indications For Use:
INDICATIONS FOR USE:
The Transitional Implants are designed for temporary use in edentulous sites. The primary purpose is to provide provisional prosthetic devices to protect the permanent implants from premature loading during the healing period. They are used to support bridges and dentures.
Additional uses are inter-radicular transitional applications, immediate splinting stability, full and partial edentulism and using minimally invasive surgical interventions.
The target population is determined when there is inadequate bone for wider implants as well as for patients wishing immediate functional loading. The transitionals are to be used in a clinical site by a qualified dentist experienced in placing dental implants.
Prescription Use Yes (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)
Susan Quares
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
3645
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