(92 days)
The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Anchor is an abutment for endosseous implants.
Here's an analysis of the provided text regarding the Locator Implant Anchor, broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Threshold | Reported Device Performance (Locator Implant Anchor) | Reported Device Performance (Predicate: ZAAG Implant Anchor) |
|---|---|---|---|
| Removal Retention Force | 3.0 lbs to 5.0 lbs | Mean: 4.7 lbs (SD = 0.207) | Mean: 4.2 lbs (SD = 0.483) |
| Fatigue Strength | ≥ 175 lbs (after 5M cycles) | ≥ 175 lbs (shared component) | ≥ 175 lbs (shared component) |
2. Sample Size Used for the Test Set and Data Provenance
- Removal Retention Force: The sample size is not explicitly stated. It mentions "Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor," implying that multiple measurements were taken for each device, but the number of devices or measurements is not provided.
- Fatigue Strength: The sample size for fatigue testing is not explicitly stated. It refers to "the Angle Correction Base," indicating a specific component was tested.
- Data Provenance: Not specified. The document does not indicate the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this submission. The device is a physical medical device (implant abutment), and the testing described involves objective physical measurements (retention force, fatigue strength) rather than subjective expert assessment of data like images or patient outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. As a physical device with objective measurements, there is no need for expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This information is not applicable. The device is an implant abutment, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical implant abutment and does not involve an algorithm.
7. The Type of Ground Truth Used
- The ground truth for the performance testing is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.
- For removal retention force, the ground truth is the direct measurement of force required to remove the anchor.
- For fatigue strength, the ground truth is the direct measurement of the force sustained after a specified number of cycles.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The comparison is made against a predicate device.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for this device.
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ZEST ANCHORS. INC.
MAR 1 7 2000
Attachment 6
510 (k) Summary of Safety and Effectiveness Information
Preparation Date: December 15, 1999 Zest Anchors, Inc. 2061 Wineridge Place #100 Escondido, CA 92029
Phone # 760-743-7744 Fax # 760-743-7975 Contact Person: Paul Zuest, President
Trade Name: Locator Implant Anchor Common Name: Abutment for Endosseous Implant Classification Name: Endosseous Dental Implant (accessory) 76DZE
The legally marketed device to which our firm is claiming equivalence is identified as the ZAAG Implant Anchor manufactured by Zest Anchors, Inc., and cleared for market under K934668. The predicate device is an abutment for endosseous implants which is intended for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The 510 (k) notification is based upon the fact that there are no significant differences between the Locator Implant Anchor (subject of this submittal) and the ZAAG Implant Anchor (predicate device) in terms of indications for use, design, and materials.
The most significant functional requirement of the devices is the value of the retentive force. Experience has shown that it should fall between 3.0 pounds and 5.0 pounds. Removal retention force was measured for both the Locator Implant Anchor and the ZAAG Implant Anchor. Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor.
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Safety of the devices can be influenced by their ability to withstand occlusal forces in a divergently placed implant fixture. The Locator Implant Anchor and ZAAG Implant Anchor share the exact same Angle Correction Base which threads into a mal-aligned endosseous implant. Results of fatigue testing of the Angle Correction Base show that, under the most severe conditions (25 degree angled component with a 4mm gingival cuff height), after 5 million cycles of compression testing, the fatigue strength of the attachment components is still at least 175 pounds.
In conclusion, this 510 (k) Summary is based upon the facts drawn from the results of testing which indicate the determination of substantial equivalence between the Locator Implant Anchor (subject of this submittal) and the ZAAG Implant Anchor (predicate device).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2000
Mr. Paul Zuest President Zest Anchors, Inc. 2061 Wineridge Place, Suite 100 Escondido, California 92029
Re : K994257 Locator Implant Anchor Trade Name: Requlatory Class: III Product Code: DZE Dated: December 15, 1999 Received: December 17, 1999
Dear Mr. Zuest:
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 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 controls provisions The general controls provisions of the Act 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. ಕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of
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Page 2 - Mr. Zuest
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 leqally 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) 594-4690. 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" (21 CFR 807.97). Other general 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.qov/cdrh/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
Enclosure
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Page 1 of of l
510(k) Number (if known): K99-4257
Device Name: Locator Implant Anchor
Indications For Use: The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rump
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.