BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

K041655 · Cowellmedi Co., Ltd. · DZE · Sep 8, 2004 · Dental

Device Facts

• Record ID: K041655
• Device Name: BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
• Applicant: Cowellmedi Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. Bio Plant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.

Device Story

BioPlant System consists of precision-machined, root-form endosseous dental implants, abutments, and accessory fixtures. Implants are surgically inserted into the jawbone to achieve osseointegration, serving as a foundation for prosthetic restorations. Components are manufactured from commercially pure (CP) titanium or titanium alloy; some accessories use gold alloy. Implants feature a threaded, self-tapping design with an external hex and are available in diameters of 3.3–6.0 mm and lengths of 7.0–18 mm. Surface finishes include smooth (machined) or textured (abrasive blasted). The system is used by dental surgeons in clinical settings for single or two-stage procedures. Output is a stable, osseointegrated implant providing an anchor for prosthetic attachments, enabling restoration of chewing function. The device is provided sterile via irradiation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including mechanical fatigue testing (5 million cycles at 25kg load, 30° off-axis) and static shear testing per ISO 14801, demonstrating acceptable yield points and structural integrity.

Technological Characteristics

Materials: Commercially pure (CP) titanium, titanium alloy, gold alloy. Design: Threaded, self-tapping, external hex, root-form. Dimensions: 3.3–6.0 mm diameter, 7.0–18 mm length. Surface: Machined or abrasive blasted. Sterilization: Irradiation (SAL 10^-6). Connectivity: None (mechanical device).

Indications for Use

Indicated for surgical placement in partially or fully edentulous mandibles and maxillae (type I or II bone) to provide a foundation for single or multiple-unit restorations (cemented, screw-retained, or over-denture) and fixed bridgework. Contraindicated in patients with insufficient bone width/height, poor bone quality, poor oral hygiene, heavy smoking/tobacco abuse, blood disorders, uncontrolled diabetes, or systemic/local infections.

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

• Branemark System - Nobel Biocare (K925777, K925779, K961728, K971706, K974140, K992937, K993595, K022562)
• 3i Restorative Implant Systems (K983347, K965077, K934126, K935544, K022009, K022113)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cowell Medi Bio Plant System. The logo features the words "COWELL MEDI" in bold, black letters, with the word "COWELL" encircled by a black oval. Below "COWELL MEDI" are the words "Bio Plant System" in a smaller font.

Head office Head office
ADDRESS : Dong-ju Bldg 2F 45-3, Kaya-IDong, BusanJin-Gu, Busan, Korea
ADDRESS : Dong-ju Bldg 2F 45-3, Kaya-1Dong, Bay : 82-51, 806-2554 FAX : [phone] TEL : [phone] Eactory Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea FAX : [phone] TEL : [phone]

http://www.cowellmedi.com - 8 2004 K# 041655 mmary per 21 CFR 807.92 19 January 2004 Date: RA/QA International, L.L.C. (Mr. Martin Leighton) US Agent / Contact: 161 Little Bay Road Newington, NH 03801 Tel. [phone] Cowell Medi Co., Ltd. Manufacturer: Cowell Medi Co., Ltd.
Dongju Bldg. 2F., 45-3, Gaya 1 Dong, Busanjin-Gu, Busan, 614-800, Korea Tel: [phone] Fax.: [phone] Contact Point: Mr. Soo-Hong Kim BioPlant System Proprietary Name: Endosseous Dental Implant Common Name: Endosseous implants, surgical components, and prosthetic attachments Classification Name: Branemark System - Nobel Biocare: K925777, K925779, K961728, K971706, Predicate Devices: Branemark System - Nooel Diocare: 1592877 3 i Restorative Implant Systems
K974150 K992937, K993595, K022562 and 31 K834186, K032600 K974130 K992957, K993375, K922302 and 73034126, K935544, K022009, K022113 The Bio Plant System includes a variety of types and sizes of precision-machined Device Description: I he B10 Plant System implants, abutments and accessory fixtures manufactured from self-fapping rool-form inforants, abutinents and soccess of sements and screws
biocompatible, commercially pure (CP) titanium idensesses titenium or gold biocompatible, commercially pure (Or) thanompatible, wrought titanium or gold
(accessory fixtures) are manufactured from biocompatible, would alsotures, and (accessory Tixiures) are manufactured from broesen with hex-lock features and alloy. The implants are service (abrasive blasted) surface finish. Implants range either smooth (0right) of textured (ustable (as a mm to 18 mm in length. The implants are intended to be surgically inserted into the upper and/or lower jawbone implants are intended to be surgically inserted this are upper while providing a stable and serve as a substitute of replacement toosh and insertion instruments, for the foundation for restorations. Drin sequences, arms as a specified and available. BioPlant Systems refer to sets of root form endosseous dental implants and Indication for Use: BioPlant Systems Teler to sets of Toot-Tormt Systems are designed for use in compant surgery and are intended to be in a manor in which they (they (the implants) integrate with the bone (osseointeration). The BioPlant abutment systems implants) integrate with the bone (osseemeering thant process from healing thru
include various abutments designed to enable the implanted include various abutinents designed to enable and that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a under controlled conditions, a successfully obsermospand surface of the titanium firm and direct connection between the fring stage surgical procedures. Bio Plant implant. BloPlant Implants are for single of two stage on for fully edentulous Systems are intended for Intinculate placement of single or multiple-unit mandibles and maxinac (type 1 of 11 oone), "stained, or over-denture restorations,

applications may be splinted with a bar.

restorations including, ceinent reamed, sorew fetamon, as a common of the

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OWER MEDI

Head office
ADDRESS : Dong-ju Bldg 2F 45-5, . . .ya-IDong, BusanJin-Gu, Busan, Korea
TEL : [phone] Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
TEL : [phone]

http://www.cowellmedi.com

able, 510(k) Summary per 21 CFR 807.92: Predicate Device(s) Compariso

| ATTRIBUTE /<br>CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM<br>(Submitted Product) | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Implant Innovations, Inc. (3i) |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| "K" numbers | K | K925777, K925779, K961728, K971706,<br>K974140 K992937, K993595, K022562 | K983347, K965077, K934126, K935544,<br>K022009, K022113 |
| Proprietary Name | BioPlant System | Brånemark System® | 3i Restorative Dental Implant Systems |
| CFR Section | 872.3640 | SAME | SAME |
| Pro-code | DZE & NHA | SAME | SAME |
| Classification name | Endosseous Dental Implant and Abutment Device | SAME | SAME |
| Intended / Indications for use: | BioPlant Systems refer to sets of root form<br>endosseous dental implants and compatible<br>implant abutment systems. BioPlant Systems are<br>designed for use in dental implant surgery and<br>are intended to be used in a manor in which they<br>(the implants) integrate with the bone<br>(osseointegration). The BioPlant abutment<br>systems include various abutments designed to<br>enable the implant process from healing thru<br>final restoration. Clinical studies have<br>demonstrated that, when surgically implanted<br>hinder controlled conditions. a successfully<br>osseointegrated implant will achieve a firm and<br>direct connection between the living bone and<br>surface of the titanium implant. BioPlant | (Functionally the same)<br>Brånemark System implants are for single-stage<br>or two-stage surgical procedures and cement or<br>screw retained restorations. The Brånemark<br>System implants are intended for immediate<br>placement and function on single tooth and or<br>multiple tooth applications recognizing<br>sufficient bone stability (type I or II bone) and<br>appropriate occlusal loading, to restore chewing<br>functions. Multiple applications may be splinted<br>with a bar. The Brånemark Abutments System is<br>a set of cemented or screw retained preparable<br>abutments which are secured to an endosseous<br>implant and is intended to function as an anchor<br>to which prosthetic devices, such as artificial | (Functionally the same)<br>3i Dental Implant Systems are indicated for<br>surgical placement in the upper or lower jaw to<br>provide a means for prosthetic attachment to<br>restore a patients chewing function. Abutments<br>and accessories are indicated for use in surgical<br>and restorative applications when placing dental<br>implants. |
| ATTRIBUTE /<br>CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM<br>(Submitted Product) | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Implant Innovations, Inc. (3i) |
| Continued:<br>Intended / Indications for use: | implants are for single or two-stage surgical<br>procedures. Bio Plant Systems are intended for<br>immediate placement in partially or fully<br>edentulous mandibles and maxillae (type I or II<br>bone), in support of single or multiple-unit<br>restorations including; cement retained. screw<br>retained, or over-denture restorations. and<br>terminal or intermediate abutment support for<br>fixed bridgework. Multiple tooth applications<br>may be splinted with a bar. | teeth. may be attached using dental cement to<br>restore a patient's chewing function. | |
| Design -(Implants) | Threaded. self tapping. external hex, root-form | SAME | SAME |
| Diameter-(Implants) | 3.3 - 6.0 mm | 3.3 - 5.0 mm | 3.25 - 6.0mm |
| Length -(Implants) | 7.0-18 mm | SAME | SAME |
| Material-(Implants) | Commercially pure (CP) titanium (Ti) | SAME | SAME |
| Coating-(Implants) | Non-coated | Non-coated and Coated (HA) | Non-coated and Coated (HA) |
| Surface Finish (Implants) | Machined or roughened / textured (abrasive<br>blasted). If roughened. the transmucosal part<br>maintains a smooth machined finish to allow for<br>the attachment of epithelial tissue. | EQUIVALENT: Machined or roughened<br>/textured via proprietary roughening method. If<br>roughened, the transmucosal part maintains a<br>smooth machined finish to allow for the<br>attachment of epithelial tissue. | EQUIVALENT: Machined or roughened<br>/textured via proprietary roughening method. If<br>roughened, the transmucosal part maintains a<br>smooth machined finish to allow for the<br>attachment of epithelial tissue. |
| ATTRIBUTE /<br>CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM<br>(Submitted Product) | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Implant Innovations, Inc. (3i) |
| Design -(Abutments) | Abutments (straight, no angle): healing,<br>cemented and non-cemented / screw attached.<br>Miniscone. Estheticone. temporary and UCLA<br>type, with associated cylinder and coping<br>screws. | EQUIVALENT: but also include angled and<br>universal abutments | EQUIVALENT: but also include angled and<br>universal abutments |
| Materials-(Abutments) | CP Ti, Ti alloy, or gold alloy | CP Ti, Ti alloy, gold alloy and ceramic | CP Ti, Ti alloy, gold alloy and plastic |
| Materials-(screws) | CP Ti, Ti alloy, or gold alloy | SAME | SAME |
| Color additives-(Implants &<br>Abutments) | There are no color additives used in any of the<br>materials of the components of the device. | SAME | SAME |
| Accessories available - drills<br>Drivers: | point, twist. tap. pilot, countersink. hand-driver.<br>machine driver, mount driver | EQUIVALENT | EQUIVALENT |
| Provided Sterile? - (Implants<br>& Abutments) | YES | YES | YES |
| Sterilization Method(s) | Irradiation, SAL 10-6 | Various Methods | SAME |
| Packaging- (Implants) | Polymeric ampul in peel-open blister pack | Glass ampul in peel-open blister pack | Heat sealed peel-open nylon pouch |
| Packaging- (Abutments /<br>screws) | Various methods | EQUIVALENT | EQUIVALENT |
| Contraindications (from<br>Instructions for use (IFU)<br>package insert labeling) | Bio Plant System implants should not be placed<br>in patients where the retaining jawbone is too<br>diminished to provide adequate width or height<br>to surround the implant. Failure to | FUNCTIOALLY EQUIVALENT: (from IFU)<br>Pre-operative patient evaluation is necessary to<br>determine any factors which put the patient risk<br>from the implant placement procedure itself of | FUNCTIOALLY EQUIVALENT: (from 510(k)<br>Summary) Implants should not be used in cases<br>where the remaining jawbone is too diminished<br>to provide adequate width or height to surround |
| ATTRIBUTE /<br>CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM<br>(Submitted Product) | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE<br>DEVICES OF<br>Implant Innovations, Inc. (3i) |
| Continued:<br>Contraindications (from<br>Instructions for use (IFU)<br>package insert labeling) | osseointegration or subsequent loss of<br>osseointegration may occur in cases where there<br>is insufficient available bone, poor bone quality,<br>poor oral hygiene, heavy smoking or tobacco<br>abuse, or medical conditions such as blood<br>disorders or uncontrolled diabetes. | factors that may effect healing capacities of<br>either the bone or associated soft tissue. Dental<br>implants should not be used in patients who are<br>unfit medically for a general oral surgical<br>procedure. For patients who have local of<br>systemic factors which could be expected to<br>interfere with the healing process of either bone<br>or soft tissue (e.g. connective tissue disorders,<br>steroid therapy, infections in bone, cigarette<br>smoking) the potential benefits and risks of<br>treatment need to be carefully evaluated. | the implant. Lack of osseointegration or<br>subsequent implant failure may occur in cases<br>where there is insufficient available bone or<br>poor bone quality, poor oral hygiene, heavy<br>smoking or tobacco abuse, or medical<br>conditions such as blood disorders, infection(s),<br>vascular impairment at surgical site. |
| | Contraindications associated with elective<br>surgery should be observed. | In addition, the patients need to have an<br>adequate volume of residual bone for placing<br>sufficient size and numbers of implants to<br>support the anticipated functional loads the<br>patient will subject these implants to. | uncontrolled diabetes, heavy smoking or<br>tobacco abuse, drug or alcohol abuse, chronic<br>high dose steroid therapy, medical conditions<br>such as blood clotting disorders, current or<br>ongoing anticoagulant therapy, metabolic bone<br>disease or other metabolic or systemic disorders<br>which may adversely affect bone or wound<br>healing or cases in which the available bone is<br>too diminished to provide adequate width or<br>height to adequately hold implants and<br>restorative appliances. |
| | Possible contraindications: Chronic bleeding<br>problem; psychological impairment; metabolic<br>bone or connective tissue diseases; treatment<br>with corticosteroids; certain cardiac and<br>vascular diseases; tobacco usage diabetes<br>(uncontrolled); treatment with chemotherapeutic<br>agent; chronic renal disease; poor patient oral<br>hygiene; bruxing, alcoholism. | Insufficient size or numbers of implants to<br>support biomechanical loads or undesirable<br>positioning of the implants can lead to<br>mechanical failure including fatigue fracture of<br>implants, prosthetic screws or abutment screws. | |
| | Temporary contraindications: Systemic<br>infection; local oral or respiratory infection. | Implant placement and prosthetic design must<br>accommodate individual patient conditions such | |
| | Anatomical or pathological contraindications:<br>Insufficient alveolar bone width and height to<br>surround the implant with at least one<br>millimeter of bone, both buccally and lingually<br>to the most superior aspect of the implant…