REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM

K991114 · Lifecore Biomedical, Inc. · DZE · Jul 14, 1999 · Dental

Device Facts

• Record ID: K991114
• Device Name: REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
• Applicant: Lifecore Biomedical, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of titanium endosseous implants, abutments, and surgical/restorative instrumentation. Implants feature titanium plasma spray (TPS) coating on the submerged portion and a machined surface on the non-submerged portion to facilitate single-stage surgical procedures. System includes various abutment options (Indexed, COC, O-Ring) for fixed or overdenture restorations. Used by clinicians in dental settings for patients with edentulous spaces. Clinician selects components based on clinical situation; implants are placed into bone to support prosthetic restorations. Benefits include elimination of second-stage uncovery surgery required by two-stage systems.

Clinical Evidence

Bench testing only. Testing included dimensional inspections, mechanical strength analysis, electrochemical corrosion evaluation (artificial saliva exposure), and mechanical properties analysis of the plasma spray coating. All results were within acceptable limits.

Technological Characteristics

Endosseous dental implant; material: CP Titanium (Grade 4); surface: Titanium Plasma Spray (TPS) coating; interface: Locking Taper; dimensions: 4.1mm/4.8mm diameter, 1.8mm/2.8mm collar height; sterilization: Gamma radiation; components: surgical/restorative instrumentation, abutment systems (Indexed, COC, O-Ring).

Indications for Use

Indicated for patients with completely or partially edentulous maxillae or mandibles requiring support for crowns, bridges, or overdentures, provided there is sufficient alveolar bone width (at least 1mm buccally and lingually).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ITI 4.1mm Solid Screw Implant and Accessories (K894595, K920768)
• Restore Self-Tapping Implant System (K924589)

Submission Summary (Full Text)

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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: [phone].

## 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, and<br>Restore 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

4. "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 Regular<br>Diameter Single<br>Stage (RDS) TPS<br>Dental Implant | ITI 4.1 mm Solid<br>Screw Implant<br>(K894595, K920768) | Restore Self-Tapping<br>Implant (K924589) |
| | Identical to<br>predicate devices | Surgical placement in<br>maxillary and/or<br>mandibular arch to<br>support crowns,<br>bridges, overdentures<br>in edentulous or<br>partially edentulous<br>patients | Indicated for single<br>edentulous spaces,<br>large edentulous<br>segments between<br>teeth, unilateral and<br>bilateral free-end<br>saddle areas, and the<br>totally edentulous<br>mandibles and<br>maxillae. |
| Material: | CP Titanium<br>(Grade 4) | CP Titanium (Grade<br>4) | CP Titanium (Grade<br>3) |
| Design | | | |
| External screw<br>threads | YES | YES | YES |
| Implant Body<br>Diameter (mm) | 4.1, 4.8 | 4.1, 4.8 | 3.75, 4.0 |
| Shoulder<br>Diameter (mm) | 4.8 | 4.8 | 4.089 |
| Collar Height<br>(mm) | 1.8, 2.8 | 1.8, 2.8 | 0.81 |
| Lengths | 8.0, 10.0, 12.0,<br>14.0, 16.0 | 8.0, 10.0, 12.0, 14.0,<br>16.0 | 8.0, 10.0, 11.5, 13.0,<br>15.0, 18.0 |
| One stage | YES | YES | NO |
| Implant/abutment<br>interface | Locking Taper | Locking Taper | External Hex |
| Cutting Flute | YES | NO | YES |
| TPS Coating | YES | YES | YES |
| Gamma sterilized | YES | YES | YES |
| Attachments | | | |
| Screw-retained<br>restoration<br>system | YES (Indexed<br>Abutment<br>System) | YES (Octasystem®) | YES (ONE System<br>Abutment, UCLA<br>Abutment System) |
| Cemented<br>restoration<br>system | YES (RDS COC<br>Abutment<br>System) | YES (Solid Abutment<br>System) | YES (COC Abutment<br>System) |
| Overdenture<br>restoration<br>system | YES (RDS O-<br>Ring Abutment<br>System) | YES (Retentive<br>Anchor System) | YES (Dalla Bona and<br>O-Ring Abutment<br>Systems) |
| Instruments<br>(surgical and<br>restorative) | 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 Implant<br>and Accessories | Restore Self-tapping Implant<br>System |
|------------------------------------------------------------|-------------------------------------------------------------------|
| Institut Straumann AG<br>CH-4437 Waldenburg<br>Switzerland | Lifecore Biomedical, Inc.<br>3515 Lyman Blvd.<br>Chaska, MN 55318 |
| Premarket Notification<br>Number: K894595, K920768 | Premarket Notification Number:<br>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 [phone]. 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 [phone] 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 [phone] or at its to at its toll-free number [phone] 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