MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM

K994205 · Lifecore Biomedical, Inc. · DZE · Feb 29, 2000 · Dental

Device Facts

• Record ID: K994205
• Device Name: MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
• Applicant: Lifecore Biomedical, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lifecore's Stage-1™ Dental Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas: - Support of fixed (cement retained) restorations utilizing abutment options. . - Support of fixed detachable (screw retained) prosthetics utilizing multiple abutment . options. - . Overdenture retention by means of an o-ring or bar appliance. - Terminal or intermediate abutment support for fixed bridgework. . - Free standing restorations without involvement of adjacent dentition when the . locking taper is engaged.

Device Story

Stage-1™ Dental Implant System comprises root-form dental implants, abutment systems, and surgical/restorative instrumentation (drills, taps, drivers). Implants feature titanium plasma spray (TPS) coating on the submerged portion for osseointegration and a smooth machined collar for epithelial tissue attachment. System enables single-stage surgical procedures, eliminating the need for a second uncovery surgery. Clinicians (dentists/oral surgeons) use the system to provide cement-retained, screw-retained, or overdenture-type restorations. Components are packaged separately for clinical flexibility. The device is compatible with ITI Straumann 4.1mm and 4.8mm Solid Screw Implant systems, allowing interchangeable use of implants, prosthetics, and instrumentation. Clinical benefit includes restoration of function and aesthetics in edentulous or partially edentulous patients.

Clinical Evidence

Bench testing only. Evidence includes dimensional inspections, abrasion testing for TPS coating strength, and electrochemical corrosion evaluation of uncoupled and coupled implant/restorative alloys in artificial saliva. Compatibility testing verified dimensional accuracy and mating performance with ITI Straumann components using precision instruments (calipers, SEM, video measuring). No clinical data presented.

Technological Characteristics

Materials: CP Titanium (Grade 4). Design: Root-form, external screw threads, locking taper implant/abutment interface. Dimensions: 4.1mm/4.8mm diameter, 1.8mm/2.8mm collar height, 8.0-16.0mm lengths. Surface: Titanium Plasma Spray (TPS) coating. Sterilization: Gamma radiation. System includes surgical/restorative instrumentation. Compatible with ITI Straumann 4.1mm/4.8mm systems.

Indications for Use

Indicated for support of crowns, bridges, or overdentures in completely and partially edentulous maxillary and mandibular arches in patients with sufficient alveolar bone width and height to provide at least 1mm of bone surrounding the submerged implant portion 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 and 4.8mm Solid Screw Implant and Accessories (K894595, K920768)
• Regular Diameter Single Stage TPS Dental Implant System (K991114)

Submission Summary (Full Text)

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FEB 2 9 2000

K9941205

# Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

Note: With the exception of the Identification of Equivalent Devices, this section is identical to the original 510(k)(K991114) or the Add-to-File submitted November 30, 1999 (Section 9: Compatibility Testing).

# 1. Submitter's Name / Contact Person

Carolyn Anderson, Requlatory Specialist Lifecore Biomedical, Inc. Ph: 612-368-6324 Fax: [phone].

# 2. General Information

| Trade Name | Stage-1™ Single Stage Implant, TPS, 4.1mm, 1.8mm Collar (RDS)Stage-1™ Single Stage Implant, TPS, 4.1mm, 2.8mm Collar (RDS)Stage-1™ Single Stage Implant, TPS, 4.8mm, 1.8mm Collar (RDS)Stage-1™ Single Stage Implant, TPS, 4.8mm, 2.8mm Collar (RDS)Stage-1™ Indexed Abutment System (RDS)Stage-1™ COC Abutment System (RDS)Stage-1™ O-Ring Abutment System (RDS) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | Single Stage Dental Implant |
| Classification Name | Endosseous Implant |
| Identification of<br>Equivalent Devices | ITI 4.1mm and 4.8mm Solid Screw Implant and Accessories (K894595, K920768), manufactured by Straumann Dental,Regular Diameter Single Stage TPS Dental Implant System (K991114) by Lifecore Biomedical, Inc. |

#### 3. Device Description

The Stage-1™ Dental Implant System consists of the single-stage, root-form dental implants and associated abutment systems. which provide the clinician with cementretained, screw-retained and overdenture-type restorative options. The system also includes surgical and restorative instrumentation: drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, open end wrench and handpiece adapters. The implants, prosthetics, and surgical tools are each packaged separately to allow the clinician to choose only those components required for each clinical situation. The single-stage implant is titanium plasma spray coated on the portion of the implant that is submerged into bone. The non-submerged portion is machined smooth to allow for the attachment of epithelial tissue. This surgical procedure eliminates the need for the second (uncovery) surgery that is required in twostage implant systems.

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# 4. Intended Use

Lifecore's Stage-1™ Dental Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:

- Support of fixed (cement retained) restorations utilizing abutment options. .
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutment . options.
- . Overdenture retention by means of an o-ring or bar appliance.
- Terminal or intermediate abutment support for fixed bridgework. .
- Free standing restorations without involvement of adjacent dentition when the . locking taper is engaged.

| | Subject Device | Predicate Devices | Predicate Devices |
|----------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Lifecore Stage-1<br>Regular Diameter<br>Single Stage (RDS)<br>TPS Dental Implant<br>(K994205) | ITI Straumann 4.1 mm<br>and 4.8mm Solid<br>Screw Implant<br>(K894595, K920768) | Lifecore Regular<br>Diameter Single Stage<br>(RDS) TPS Dental<br>Implant (K991114) |
| Intended Use | Identical to predicate<br>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 | 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 |
| Material: | CP Titanium (Grade 4) | CP Titanium (Grade 4) | CP Titanium (Grade 4) |
| Design | | | |
| External screw<br>threads | YES | YES | YES |
| Implant Body<br>Diameter (mm) | 4.1, 4.8 | 4.1, 4.8 | 4.1, 4.8 |
| Shoulder Diameter<br>(mm) | 4.8 | 4.8 | 4.8 |
| Collar Height (mm) | 1.8, 2.8 | 1.8, 2.8 | 1.8, 2.8 |
| Lengths | 8.0, 10.0, 12.0, 14.0,<br>16.0 | 8.0, 10.0, 12.0, 14.0,<br>16.0 | 8.0, 10.0, 12.0, 14.0,<br>16.0 |
| One stage | YES | YES | YES |
| Implant/abutment<br>interface | Locking Taper | Locking Taper | Locking Taper |
| Cutting Flute | YES | NO | YES |
| TPS Coating | YES | YES | YES |
| Gamma sterilized | YES | YES | YES |
| Attachments | | | |
| Screw-retained | YES (RDS Indexed<br>Abutment System) | YES (Octasystem®) | YES (RDS Indexed<br>Abutment System) |
| Cemented | YES (RDS COC<br>Abutment System) | YES (Solid Abutment<br>System) | YES (RDS COC<br>Abutment System) |
| Overdenture<br>restoration system | YES (RDS O-Ring<br>Abutment System) | YES (Retentive<br>Anchor System) | YES (RDS O-Ring<br>Abutment System) |
| Instruments<br>(surgical and<br>restorative) | YES | YES | YES |

# 5. Technological Characteristic Comparisons

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#### 6. Nonclinical Tests

The Stage-1™ Dental Implant System has been tested to ensure that all design specifications have been met. Dimensional inspections are routinely performed, Abrasion testing to ensure TPS coating strength, Electrochemical Corrosion Evaluation of Uncoupled and Coupled Implant and Restorative Alloys has been performed to determine corrosion properties when exposed to artificial saliva and to determine the galvanic corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Ti-6Al-4V galvanic couples, and the Mechanical Properties of the Plasma Spray Coating have been analyzed. All have been found to be within acceptable limits.

#### 7. Compatibility

The Lifecore Stage-1™ Dental Implant System has been designed to be compatible with the ITI Straumann 4.1mm and 4.8mm Solid Screw Implant System. The compatibility testing encompassed two kinds of testing; Dimensional Testing of the predicate product and Mating Part Verification Testing.

Dimensional testing was performed using a variety of precision instruments: calipers, micrometers, optical comparators, video measuring/touch probe, toolmakers microscope, SEM, thread gauges, and plug gauges. Some internal dimensions required cross sectioning of the component in order to complete the measurement. In these instances, the component was imbedded in acrylic to prevent distortion of the dimensions prior to cross sectioning.

Mating Part Verification was performed by connecting appropriate components together using the appropriate drivers, when necessary. Mated components were examined visually to ensure components were fully seated and there was no rotational play between components. The critical implant to abutment connections and implant to cover screw connections were also examined using the video measuring machine and SEM.

The data demonstrates that the Stage-1™ Dental Implant and Prosthetics are compatible and therefore interchangeable with the ITI Straumann 4.1mm and 4.8mm Solid Screw Implants and Prosthetics. Additionally, the associated Lifecore instrumentation can be used with the ITI Straumann 4.1mm and 4.8mm Solid Screw Implant System, and the associated ITI instrumentation can be used with the Stage-1™ Dental Implant System.

#### 8. Substantial Equivalence Comparison

The Stage-1™ Dental Implant System is substantially equivalent to the following products:

| ---------------<br>Screw Implant<br>CALCO Pro<br>30000 | equilar Diameter ·<br>Single | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| CIBOR<br>મેબેસ્ટર્ટ રોગ્રેસ રેટિટ | 10 D C L T = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1<br>Dental Imbiant | |

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| Institut Straumann AG | Lifecore Biomedical, Inc. |
|--------------------------|--------------------------------|
| CH-4437 Waldenburg | 3515 Lyman Blvd. |
| Switzerland | Chaska, MN 55318 |
| Premarket Notification | Premarket Notification Number: |
| Number: K894595, K920768 | K991114 |

#### 9. Conclusion (statement of equivalence)

The data submitted in this 510(k) is in support of substantial equivalency of the Lifecore Stage-1™ Regular Diameter Single Stage (RDS) TPS Dental Implant System to the following commercially marketed devices:

- ITI 4.1 mm and 4.8 mm Solid Screw Implant (K894595, K920768) .
- Regular Diameter Single Stage TPS Dental Implant System (K991114) .

The data presented in this 510(k) supports the claim that the Stage-1 Dental Implant System Implants, Prosthetics, and Instrumentation are compatible with the ITI 4.1mm and 4.8mm Solid Screw Implants, Prosthetics, and Instrumentation. The compatibility data demonstrates that these components can be used interchangeably and are therefore, compatible.

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 Stage-1 ™ Dental Implant System. The comparative analysis demonstrates the substantial equivalence of the Lifecore Stage-1™ Dental Implant System to the predicate devices that are in commercial distribution.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

FEB 2 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carolyn Anderson Requlatory Specialist Lifecore Biomedical, Inc. 3515 Lyman Boulevard Chaska, Minnesota 55318-3051

Re : K994205

> Stage-1™ Regular Diameter Single Stage Trade Name: (RDS) TPS Dental Implant System Regulatory Class: III Product Code: DZE Dated: November 30, 1999 Received: December 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 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 Requlations, Title 21, Parts 800 to 895. A 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 requlation may result in requlatory 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 obligation you might have under sections 531 through 542 of

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Page 2 -Ms. Anderson

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Palivea Cuenta/for

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): K994205

#### Device Name:

Stage-1™ Regular Diameter Single Stage (RDS) TPS Dental Implant System

#### Indications for Use:

Note: The Indications for Use have not changed from the original 510(k), K991114.

- The Stage-1™ Regular Diameter Single Stage TPS Dental Implant System is . indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous maxillary and mandibular arches in areas with sufficient alveolar bone width and height to surround the submerged 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)

Susan Russon

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