(12 days)
Not Found
No
The summary describes a mechanical dental implant attachment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for attaching artificial teeth to a dental implant, which is a structural or restorative function rather than a therapeutic one (treating or curing a disease or medical condition).
No
The device is described as an attachment for affixing artificial teeth to a dental implant, which is a restorative function, not a diagnostic one.
No
The device description clearly states it is a "three-piece attachment" with physical components (top, base, hex screw) that are cemented into a dental implant. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to attach artificial teeth to a dental implant. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical attachment system for dental prosthetics. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a dental prosthetic component used for restorative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Straight Post and Core II Attachment is intended to attach artificial teeth to a dental implant.
Product codes
DZE
Device Description
The Straight Post and Core II Attachment is a three-piece attachment. The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
None
Key Metrics
Not Found
Predicate Device(s)
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
- 2001 AUG
Attachment I 510(K) Summary
BASIC Dental Implant System Straight Post and Core II Attachment
This 510(K) Summary of safety and effectiveness for the BASIC Dental Implant System Straight Post and This JTQ\x) ballimary of bareer anin accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
Applicant:
Address:
Contact Person:
Telephone / Fax / Email
Preparation Date:
Device Trade Name:
Common Name:
Classification:
Legally Marketed Predicate Device:
Description of the Straight 2-Piece Post and Core Attachment:
Intended use:
Performance Data:
Results of Clinical Study:
Conclusion:
BASIC Dental Implant Systems, Inc.
3321 Columbia NE Albuquerque, New Mexico 87107 USA
Dan Blacklock, Vice-President
505.881.1376 - Phone 505.884.1923 - Fax
July 19, 2001
BASIC Dental Implant System Straight Post and Core II Attachment
Accessory to a Dental Implant
DZE
BASIC Dental Implant System 2-Piece Post and Core Attachment K number K001259
The Straight Post and Core II Attachment is a three-piece attachment.
The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.
The Straight Post and Core II Attachment is intended to attach artificial teeth to a dental implant.
None
None
The Straight Post and Core II attachment is substantially equivalent to other existing Straight 2-Piece Post and Core attachments in commercial distribution.
1
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and appears to be extracted from a document or sign.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
AUG 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Blacklock Vice President Basic Dental Implant Systems, Incorporated 3321 Columbia, N.E. Albuquerque, New Mexico 87107-2001
K012299 Re : BASIC Dental Implant System Straight Trade/Device Name: 2-Piece Post and Core Attachment Regulation Number: 872.3640 Regulatory Class: III Product Code: DZE July 19, 2001 Dated: Received: July 20, 2001
Dear Mr. Blacklock :
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
2
Page 2 - Mr. Blacklock
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at 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. Whitehouse
Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: BASIC Dental Implant System Straight 2-Piece Post and Core Attachment
Indications for Use:
The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.
(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) |
(Division Sign-Off)
Division of Dental, Infection Control,
a - General Hospital Devices 1. Number_KADIJ99
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________