This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
This device 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, and to restore the patient's chewing function.

Device Description

The CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray.

AI/ML Overview

The provided text is a 510(k) summary for a dental implant system (CRYSTAL and CRYSTAL-SEAL Implants System). It does not contain information about acceptance criteria, device performance metrics, or a study design that would prove the device meets specific performance criteria. This document is focused on establishing substantial equivalence to pre-amendment devices and other already-cleared devices.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be inferred and what is explicitly stated concerning the lack of a traditional performance study:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
N/A (No specific performance criteria for substantial equivalence are defined in this document beyond material and design similarity to predicate devices)	N/A (No quantitative performance data is provided). The document states, "Endosseous implants, and especially those of titanium or titanium alloy, in the 'post' or 'screw' configuration, have been proved safe and effective through the years." This refers to the general category of devices, not specific performance metrics for the CRYSTAL system.

2. Sample size used for the test set and the data provenance:

N/A. No formal test set or clinical study specific to the CRYSTAL and CRYSTAL-SEAL Implants System is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices and general literature on endosseous implants.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. No test set or ground truth establishment process for performance evaluation is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This device is a dental implant, not an AI software or a diagnostic imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This device is a physical medical device (dental implant), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

N/A. Given the type of submission (510(k) based on substantial equivalence), the "ground truth" for proving safety and effectiveness relies on the long-standing history of similar pre-amendment devices and contemporary legally marketed predicate devices. The document cites literature reviews and a 10-year study (Toronto study by Zarb) on the Branemark implant technique as evidence of safety and effectiveness for endosseous implants in general, not specifically for the CRYSTAL system.

8. The sample size for the training set:

N/A. No "training set" in the context of an algorithm or AI model is applicable here.

9. How the ground truth for the training set was established:

N/A. Not applicable, as there is no training set for an algorithm.

Conclusion regarding the "study that proves the device meets the acceptance criteria":

The provided text does not describe a specific study for the CRYSTAL and CRYSTAL-SEAL Implants System that establishes acceptance criteria and directly proves the device meets them. Instead, the submission relies on the concept of Substantial Equivalence (SE).

The core argument for the device's safety and effectiveness is made by:

Similarity to pre-amendment devices: Stating that it is "equivalent to devices manufactured and sold before 1976."
Similarity to currently marketed predicate devices: Explicitly referencing K-954432 (Crystal and Crystal Plus Implants System) and other examples cleared by the FDA (e.g., Bofors Nobelpharma, Core-Vent Corp., etc.).
General acceptance and literature review: The document includes a "Clinical Discussion and Brief Literature Review" which summarizes that "Endosseous implants...have been proved safe and effective through the years." It references a Medline search, a Consensus Development Conference on Dental Implants (NIH, 1988), and specifically the Toronto 10-year study by Zarb on the Branemark implant technique. This literature supports the general safety and effectiveness of the class of devices, implying that because the CRYSTAL system is substantially equivalent in design, materials, and intended use, it also shares this established safety and effectiveness.

In essence, the "proof" is through demonstrating that the device is fundamentally the same as other devices already proven safe and effective, rather than presenting a de novo study for this specific product.

Summary

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XIV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)

A. Submitter: Clint Folsom, Crystal Medical Technology, Inc., 181 Cahaba Valley Pkwy, Pelham, AL 35124. Registration No. 51805.

I. Classification Name and Number: Endosseous Implant (76DZE),

II. Common/Usual Name: Dental Implant, Endosseous, Post (or screw)-type, titanium or titanium alloy.

III. Proprietary Name: CRYSTAL and CRYSTAL-SEAL Implants System

IV. Classification: This device is being finally classified by the Dental Devices Panel (Title 21 CFR 872.3640.

V. Performance standards: None applicable. Materials meet ASTM voluntary standards

VI. Description: The CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). See Appendix V for composition and characteristics of the titanium and/or titanium alloy used.

CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech. Inc., which were cleared under K-924112. VII. Labels and Instructions for Use are provided, as are labels for competitive products. VIII. Intended Use: These devices are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.

VII. Substantial Equivalence: This device is equivalent to devices manufactured and sold before 1976, having a U. S. classification number of 76 DZE, and those described under 21 CFR 872.3640. It is also equivalent to several devices currently on the market that have been determined by the FDA to be substantially equivalent to the above preamendment devices, particularly to Crystal and Crystal Plus System cleared by K-954432. Some examples of other equivalent products are:

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Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013, Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant,

K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buenos Aires, Argentina, Osseo. Implants System, K-915375. Genentech, Seattle WA: K-924112

VIII. Clinical Discussion and Brief Literature Review: Endosseous implants, and especially those of titanium or titanium alloy, in the "post" or "screw" configuration, have been proved safe and effective through the years. The possible adverse effects summarized in this 510(k) cover those listed by the United States classification panel [Federal Register, vol. 45, No. 251, pp 86025-6, Dec. 30, 1980], as well as to those revealed in a recent literature search. Matukas, "Medical Risks Associated with Dental Implants," states, "Little or no hard data could be found on the medical risks associated with (dental] implants." Because of the wide-spread usage of dental implants, Smith and Zarb made a careful review of the literature and proposed criteria for implant success.

A thorough computerized Medline literature search produced 585 entries. An update of this search produced 68 new review articles. The Journal of Dental Education published a special issue "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988], Vol. 52, No. 12, pp. 677-831, Dec. 1988. This added to the literature search above, with some especially pertinent reprints from the scientific literature, provide a comprehensive summary of available scientific data.

Zarb completed his report of the detailed Toronto 10-year study by concluding that "the tried and tested Branemark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient ... the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable." These results are ample evidence of the safety and effectiveness of these endosseous implants.

END OF 510(k) SUMMARY

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Mr. Clint Folsom ·President Crystal Medical Technology 181 Cahaba Valley Parkway Pelham, Alabama 35124

Re : K980442 Crystal and Crystal-Seal Implants System Trade Name: Requlatory Class: III Product Code: DZE January 30, 1998 Dated: February 4, 1998 Received:

Dear Mr. Folsom:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance withthe Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Reqister. 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 regulations.

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Page 2 - Mr. Folsom

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" (21 CFR 807.97) . Other gener 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cosenza

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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IX. Indications for Use: {Separate Page}

90444 510(k) Number: NA

Device Name: Crystal Seal™

This device 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, and to restore the patient's chewing function.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or
(Per 21 CFR 801/109)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number ka80442.

Over-The-Counter Use No

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.