(76 days)
No
The summary describes a dental implant and a modification to use stronger titanium, with no mention of AI or ML technology.
Yes
The device is a dental implant used to replace missing teeth, which is a therapeutic intervention to restore function and aesthetics.
No
The device is described as an implant for dental purposes, specifically a self-tapping screw that replaces missing teeth. Its function is to provide a base for false teeth, and the description focuses on its material strength and mechanical properties. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description clearly describes a physical dental implant made of titanium, which is a hardware component. The modification is related to the material used for this physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace missing teeth by implanting a device into the jawbone. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body.
- Device Description: The device is a dental implant made of titanium, designed to be physically placed in the jawbone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
Therefore, this device falls under the category of a medical device (specifically, a dental implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints. Per FDA-CDRH criteria for a Special 510(k), the modification does not affect the intended use or alter the fundamental scientific technology of the device and the modification to the device falls within the design controls of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jawbone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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)
Not Found
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.
K061629, K071235, K070022, K041938
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
DEC 0 4 2008
II. 510(k) SUMMARY
| 1. | SUBMITTER INFORMATION | ||
|---|---|---|---|
| A. Company Name: | B.A.S.I.C. Dental Implant Systems, Inc. | ||
| B. Company Address: | 3321 Columbia NE | ||
| Albuquerque, NM 87107 | |||
| USA | |||
| C. Company Phone: | (505)881-1376 | ||
| D. Company Facsimile: | (505)884-1923 | ||
| E. Company Contact: | Dan Blacklock - Vice President | ||
| 2. | DEVICE IDENTIFICATION | ||
| A. Device Trade Name: | B.A.S.I.C. Dental Implant System | ||
| B. Device Common Name: | Dental Implant | ||
| C. Classification Name: | Endosseous Dental Implant, root-form | ||
| D. Device Class: | Class II | ||
| E. Device Code: | DZE |
3. MODIFIED FROM DEVICE
Trade Name: B.A.S.I.C. Dental Implant System 510(k) Number: K072595
4. DEVICE DESCRIPTION & SUMMARY OF DEVICE MODIFICATION
The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.
Per FDA-CDRH criteria for a Special 510(k), the modification does not affect the intended use or alter the fundamental scientific technology of the device and the modification to the device falls within the design controls of the device.
ક. INTENDED USE
The intended use is identical to the predicate device. For reference the intended use is listed below.
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).
6. COMPARISON TO PREDICATE DEVICE (UN-MODIFIED DEVICE)
The B.A.S.I.C. Dental Implant is substantially equivalent in the following ways to the identified predicate device;
- . Identical dimensional characteristics of implants
- . Identical Indications for Use
1
II. 510(k) SUMMARY (continued)
7. COMPARISION TO OTHER PREDICATE DEVICES
For reference BASIC is including a summary of other predicate devices with cleared implants produced with titanium alloy, and that have similar dimensions.
| Device Name | 510(k) Number | Device Description | Equivalence Comparison |
|---|---|---|---|
| B.A.S.I.C. Dental | |||
| Implant Device | |||
| Modification | Pending | Implants offered in diameter | |
| sizes of 3.5mm, 4.0mm, 4.5mm, | |||
| and 6.0mm. Implants offered in | |||
| lengths of 8mm, 9mm, 11mm, | |||
| 13mm and 15mm. Implant raw | |||
| material Titanium Alloy or CP | |||
| Titanium as listed | -- | ||
| Implant Innovations | K061629 | PREVAIL available in 4.0 and | |
| 5.0mm Diameters, in lengths of | |||
| 8.5, 10, 11.5, 13, & 15mm. | |||
| Material used is Titanium Alloy | |||
| [Ti6A14V] per ASTM F-136 | SE | ||
| Zimmer Dental Inc. | K071235 | Zimmer® One-Piece Implant, | |
| 3.0mm Angled composed of | |||
| titanium alloy. | SE | ||
| MIS Dental Implant | |||
| System | K070022 | Implant Diameters 3.75, 4.10, & | |
| 4.80mm | |||
| Implant lengths 8,10,11.5,13, | |||
| &16mm produced with medical | |||
| grade 5 pure titanium | SE | ||
| BioHorizons | |||
| Implant Systems, | |||
| Inc. | K041938 | Implant Collar Heights | |
| 2, & 4mm | |||
| Implant lengths 12,15, & 18 | SE |
8. STERILIZATION AND BIOCOMPATIBILITY
Sterilization process remains the same, B.A.S.I.C. Dental Implant Systems, Inc. has contracted with Steris Isomedix Service to maintain a valid gamma-ray sterilization process in accordance with ISO 1137 (SAL 10 6) for the B.A.S.I.C. Dental Implant System. Substantiation of a routine sterilization dose will be established using the VDmax25 method, described in ISO 11137. This will meet B.A.S.I.C.'s in-house requirement and requirements for ISO 11137. Gamma sterilization for the implantable components, are provided in sterilized medical Tyvek® pouches.
2
II. 510(k) SUMMARY (continued)
9. CONCLUSION
The B.A.S.L.C. Dental Implant System is substantially equivalent to B.A.S.I.C. Dental Implant System's predicate device 510(k) number K072595 cleared on 5/09/08. The previously cleared dental implant and the proposed dental implant serve the same intended purpose, use the same techniques, and are restored by the dentist using the same methods. The material modification does not pose any health risks to the patient.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
Mr. Dan Blacklock Vice President B.A.S.I.C. Dental Implant Systems, Incorporated 3321 Columbia North East Albuquerque, New Mexico 87107
Re: K082749
Trade/Device Name: Omni-Tight Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 15, 2008 Received: November 4, 2008
Dear Mr. Blacklock:
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 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. Blacklock
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 (OS) 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 vour 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 vours.
Chih S. Lin, Ph.D.
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
5
Indication for Use
510(k) Number (if known): K082749
Device Name: Omni-Tight
Indication For Use:
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Suze Paares
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K002749