The Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.

Device Description

The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation: restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium. components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.

AI/ML Overview

This document describes the Lifecore Regular Diameter Single Stage (RDS) TPS Dental Implant System.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly established through a substantial equivalence comparison to predicate devices, rather than explicit numerical thresholds for performance metrics. The study aims to demonstrate that the subject device performs as safely and effectively as the predicate devices.

Feature / Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	Identical or highly similar intended use, materials, design, and surface characteristics to predicate devices.	The Lifecore RDS TPS Dental Implant System's intended use, materials (CP Titanium Grade 4), and design features (external screw threads, implant body diameter, shoulder diameter, collar height, lengths, one-stage design, locking taper interface, cutting flute, TPS coating, gamma sterilization) are compared directly to the ITI 4.1mm Solid Screw Implant and Accessories (K894595, K920768) and the Restore Self-Tapping Implant System (K924589). The document states that the intended use is "Identical to predicate devices" and that the "comparative analysis demonstrates the substantial equivalence."
Biocompatibility/Material Safety	Materials should be safe for implantation and demonstrate suitable performance.	CP Titanium (Grade 4) is used, matching one predicate (ITI) and being a higher grade than the other (Restore, Grade 3). Electrochemical Corrosion Evaluation and Galvanic Couple testing (Precious Alloy/CP titanium and Precious Alloy/Ti alloys in artificial saliva) were performed, and "All have been found to be within acceptable limits."
Mechanical Integrity	Device should be structurally sound and maintain its integrity under expected loads.	"Bending strength" was tested, and specifications "have been met." "Mechanical Properties of the Plasma Spray Coating have been analyzed," and "All have been found to be within acceptable limits."
Dimensional Accuracy	Device dimensions should conform to specifications.	"Dimensional inspections are routinely performed," and specifications "have been met."
Surface Characteristics	Surface treatment and properties should be comparable or superior to predicate devices.	TPS coating is present and analyzed, noted as being similar to predicate devices. "Abrasion testing to oneoro TF & Soung East and Restorative Alloys has been performed" (though the full context of this test related to surface characteristics is somewhat unclear, it implies an evaluation of surface interaction).

2. Sample Size Used for the Test Set and the Data Provenance

This submission does not describe a clinical study with a traditional "test set" of patients or data. Instead, it relies on non-clinical bench testing to demonstrate substantial equivalence.

Sample Size: Not applicable in the context of a patient-based test set. The reported tests (dimensional, bending strength, corrosion, abrasion, mechanical properties of coating) would have involved specific numbers of device samples or material specimens, but these quantities are not specified in the document.
Data Provenance: The tests are explicitly described as "Nonclinical Tests" performed on the device itself. Therefore, the data originates from laboratory and bench testing. The country of origin is not explicitly stated for the testing facilities, but the submitter is Lifecore Biomedical, Inc. located in Chaska, Minnesota, USA. The data is retrospective in the sense that these tests were conducted on the manufactured device models to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There is no human "ground truth" establishment for this type of non-clinical, bench testing. The "ground truth" for these tests would be the established engineering and materials science principles and the specifications of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no human "test set" or diagnostic assessment requiring adjudication. The assessment of test results would be against pre-defined engineering specifications and comparison to predicate device characteristics.

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

Not applicable. This document pertains to a dental implant, a physical medical device, not a diagnostic AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" in this context is the established performance and characteristics of the legally marketed predicate devices, coupled with engineering specifications and scientific principles for material safety and mechanical integrity. The goal is to show the subject device is "substantially equivalent" to these established devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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JUL 1 4 1999

K991114

Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Carolyn Anderson Ph: 612-368-6324 Fax: 612-368-4278.

2. General Information

Trade Name	Single Stage Implant, TPS, 4.1mm, 1.8mm Collar (RDS) Single Stage Implant, TPS, 4.1mm, 2.8mm Collar (RDS) Single Stage Implant, TPS, 4.8mm, 1.8mm Collar (RDS) Single Stage Implant, TPS, 4.8mm, 2.8mm Collar (RDS) Indexed Abutment System (RDS) COC Abutment System (RDS) O-Ring Abutment System (RDS)
Common / Usual Name	Single Stage Dental Implant
Classification Name	Endosseous Implant
Identification of Equivalent Devices	ITI 4.1mm Solid Screw Implant and Accessories (K894595, K920768), manufactured by Straumann Dental, andRestore Self-Tapping Implant System (K 924589), manufactured by Lifecore Biomedical, Inc.

3. Device Description

The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation:
restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those
surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium.
components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.

4. Intended Use

"Intended Goo Elleoore o Bingle Clagibles and maxillae in the following areas:

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Support of fixed (cement retained) restorations utilizing abutment options. .
Support of fixed (cement retained) roctoriations attitling multiple abutment . options.
options:
Overdenture retention by means of an o-ring or bar appliance. .
Terminal or intermediate abutment support for fixed bridgework. .
r ommal of intermediations without involvement of adjacent dentition when the . locking taper is engaged.

Feature	Subject Device	Predicate Devices
Intended Use	Lifecore RegularDiameter SingleStage (RDS) TPSDental Implant	ITI 4.1 mm SolidScrew Implant(K894595, K920768)	Restore Self-TappingImplant (K924589)
	Identical topredicate devices	Surgical placement inmaxillary and/ormandibular arch tosupport crowns,bridges, overdenturesin edentulous orpartially edentulouspatients	Indicated for singleedentulous spaces,large edentuloussegments betweenteeth, unilateral andbilateral free-endsaddle areas, and thetotally edentulousmandibles andmaxillae.
Material:	CP Titanium(Grade 4)	CP Titanium (Grade4)	CP Titanium (Grade3)
Design
External screwthreads	YES	YES	YES
Implant BodyDiameter (mm)	4.1, 4.8	4.1, 4.8	3.75, 4.0
ShoulderDiameter (mm)	4.8	4.8	4.089
Collar Height(mm)	1.8, 2.8	1.8, 2.8	0.81
Lengths	8.0, 10.0, 12.0,14.0, 16.0	8.0, 10.0, 12.0, 14.0,16.0	8.0, 10.0, 11.5, 13.0,15.0, 18.0
One stage	YES	YES	NO
Implant/abutmentinterface	Locking Taper	Locking Taper	External Hex
Cutting Flute	YES	NO	YES
TPS Coating	YES	YES	YES
Gamma sterilized	YES	YES	YES
Attachments
Screw-retainedrestorationsystem	YES (IndexedAbutmentSystem)	YES (Octasystem®)	YES (ONE SystemAbutment, UCLAAbutment System)
Cementedrestorationsystem	YES (RDS COCAbutmentSystem)	YES (Solid AbutmentSystem)	YES (COC AbutmentSystem)
Overdenturerestorationsystem	YES (RDS O-Ring AbutmentSystem)	YES (RetentiveAnchor System)	YES (Dalla Bona andO-Ring AbutmentSystems)
Instruments(surgical andrestorative)	YES	YES	YES

5. Technological Characteristic Comparisons

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6. Nonclinical Tests

The RDS TPS Dental Implant System has been tested to ensure that all design specifications have been met. Dimensional inspections are routinely performed, Specifications have boom new Billions strength, Electrochemical Corrosion Evaluation Abrasion testing to oneoro TF & Soung East and Restorative Alloys has been performed to or oncoupled and Outplou implain a exposed to artificial saliva and to determine the Gelemine Corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Tigalvanic couples, and the Mechanical Properties of the Plasma Spray Coating have been analyzed. All have been found to be within acceptable limits.

7. Substantial Equivalence Comparison

The RDS TPS Dental Implant System is substantially equivalent to the following products:

TI 4.1 mm Solid Screw Implantand Accessories	Restore Self-tapping ImplantSystem
Institut Straumann AGCH-4437 WaldenburgSwitzerland	Lifecore Biomedical, Inc.3515 Lyman Blvd.Chaska, MN 55318
Premarket NotificationNumber: K894595, K920768	Premarket Notification Number:K924589

8. Conclusion (statement of equivalence)

The data submitted in this 510(k) is in support of substantial equivalency of the Lifecore Regular Diameter Single Stage (RDS) TPS Dental Implant System to the following commercially marketed devices:

ITI 4.1 mm Solid Screw Implant (K894595, K920768) .
Restore Self-Tapping Implant (K924589) .

These current products as defined by their product literature, demonstrate the basis for the substantial equivalency relative to indications, materials, design, and surface characteristics. The intended use of these devices is the same as the Lifecore RDS TPS Dental Implant System. The comparative analysis demonstrates the substantial equivalence of the Lifecore RDS TPS Dental Implant System to the predicate devices that are in commercial distribution.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1999

Ms. Carolyn Anderson Regulatory Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

Re : K991114 Trade Name: Regular Diameter Single Stage (RDS) TPS Dental Implant System Regulatory Class: III Product Code: DZE March 31, 1999 Dated: Received: April 1, 1999

Dear Ms. Anderson:

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 with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through poriodic 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.

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Page 2 - Ms. Anderson

Please note: this response to your premarket notification Please note: this response to your premarkne might have under
submission does not affect any obligation you might have under submission does not after any one for devices under the sections 531 through 342 or the not spoorsions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as the FDA This letter will allow you co began and fification. The FDA described in your 510(K) prematic normalence of your device to a legally
finding of substantial equivalence of acclacitication for your finding of substantial equivalence of yolassification for your marketed predicate device results in a crabbilities. The market.

If you desire specific advice for your device on our labeling If you desire specific advice tor yourselves and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Farc ove and services), please contact the Office of yitro diagnostic devices), prease conomaly, for questions on Compliance at (301) 334-4622. Addressed in please contact
the promotion and advertising of your device, please no the promotion and advertusing or your acsaces promotion of complease note the Office of Compliance at (301) 534 1039 feesence to Other general Che regulacion encribed (21 CFR 807 97). premation on your responsibilities under the Act may be information on your responsiblically Manufacturers Assistance obtained from the Division of Smart Hanar Handre (301) 443-6597 or at its to at its toll-free number (600) 636-2041 of (600) 2007
its internet address "http://www.fdf.gov/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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INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Devilos Name:

Indications for Use:

The Regular Diameter Single Stage TPS Dental Implant System is indicated for use . in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ (Per 21 CFR 801.109)

Susan Runny

510(k) Number

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.