(21 days)
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 suprastructures (false teeth).
The BASIC Dental Implant is an endosseous dental implant.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
Specifically:
- Acceptance Criteria and Reported Device Performance: The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, no table can be created.
- Sample Size and Data Provenance (Test Set): Not applicable, as no study results are reported.
- Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
- Adjudication Method (Test Set): Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no study is detailed.
- Standalone Performance Study: Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
The document is a 510(k) summary for the BASIC Dental Implant System Implant. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (BASIC Dental Implant System, K960868), which allowed it to be marketed without new clinical performance data. The FDA letter confirms the substantial equivalence determination.
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NOV 2 8 2001
Attachment I 510(K) Summary BASIC Dental Implant System Implant
KOBESQ
This 510(K) Summary of safety and effectiveness for the BASIC Dental Implant is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | BASIC Dental Implant Systems, Inc. |
|---|---|
| Address: | 3321 Columbia NEAlbuquerque, New Mexico 87107USA |
| Contact Person: | Dan Blacklock, Vice-President |
| Telephone / Fax / Email | 505.881.1376 - Phone505.884.1923 - Fax |
| Preparation Date: | October 30, 2001 |
| Device Trade Name: | BASIC Dental Implant System Implant |
| Common Name: | Dental implant |
| Classification: | DZE |
| Legally Marketed Predicate Device: | BASIC Dental Implant SystemK960868 |
| Description of the Implant: | The BASIC Dental Implant is an endosseous dental implant. |
| Intended use: | The Implant for dental purposes, used to replace missingdental 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 suprastructures (false teeth). |
| Performance Data: | None |
| Results of Clinical Study: | None |
| Conclusion: | The BASIC dental implant is substantially equivalent toprevious BASIC dental implants in commercial distribution. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or other bird-like figure, with its wings spread and tail feathers flowing downwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Mr. Dan Blacklock Vice President Basic Dental Implant Systems, Incorporated 3321 Columbia, N.E. Albuquerque, New Mexico 87107-2001
Re: K013682
R015062
Trade/Device Name: Modification To Basic Dental Implant System Regulation Number: 872.3640 Regulation Name: Dental Implant Regulatory Class: III Product Code: DZE Dated: October 30, 2001 Received: November 7, 2001
Dear Mr. Blacklock:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaler of the device is substantially equivalent (for the referenced above and have determined the active is emarketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate Collinetee prior to that have been reclassified in accordance with the provisions of Amendinents, of to devices that nave oose (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment 1 10 (110) - market the device, subject to the general approval application (1 Miry) - 1 Sue general controls provisions of the Act include confors provisions of the rec. The genting 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 II your device is classified (see aso voy into controls. Existing major regulations affecting (PMA), it may of subject to such adament. Could Regulations, Title 21, Parts 800 to 898. In the Colors of your device can be found in the South one one ming your device in the Federal Register.
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 mean that I DA nas made a actes and regulations administered by other Federal agencies.
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Page 2 - Mr. Blacklock
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Fict b requirements) and manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceming (21 cms (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 I hus letter will anow you to begin main the your substantial equivalence of your device to 510(K) premarket noutleated. " The 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 II you desire specific ad not 100 for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 609110113. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promotio Office of Comphanoo at (301) as contact the Office of Compliance at (301) 594-4639. advertising or your the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothication (210) It it a r 0779).
the Act may be obtained from the Division of Small Manufacturers, International and ull Act may be obtained in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE STATEMENT
KO13682
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: BASIC Dental Implant System Dental Implant
Indications for Use:
The Implant for dental purposes, used to replace missing dental I ne Inipiant for dental parphant is self-tapping (threads) and is organs (tectif). The Iniptarmed in the jawbone. Upon healing, serewed into a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Susan Runno
(Division Sign-Off) -vision of Dental, Infection Control, ് r Long Number
§ 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.