(82 days)
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.
The Bio Plant System includes a variety of types and sizes of precision-machined self-tapping root-form implants, abutments and accessory fixtures manufactured from biocompatible, commercially pure (CP) titanium or biocompatible, wrought titanium or gold alloy. The implants are available with hex-lock features and either smooth (bright) or textured (abrasive blasted) surface finish. Implants range in diameter from 3.3 mm to 6.0 mm and in length from 7 mm to 18 mm. The implants are intended to be surgically inserted into the upper and/or lower jawbone and serve as a substitute or replacement tooth while providing a stable and secure foundation for restorations. Drill sequences, arms and insertion instruments, as specified, are available.
The provided text describes the Cowell Medi BioPlant System, an endosseous dental implant system, and its acceptance criteria as defined for its 510(k) submission to the FDA. The submission relies heavily on demonstrating substantial equivalence to predicate devices and provides non-clinical testing data to support this claim, rather than new clinical trials.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cowell Medi BioPlant System are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices (Nobel Biocare's Brånemark System and Implant Innovations, Inc. (3i) Dental Implant Systems). The performance criteria are therefore linked to matching or being functionally equivalent to these predicates across various attributes.
| Attribute / Characteristic | Acceptance Criteria (as per Predicate Devices) | Reported Device Performance (COWELL MEDI BIOPLANT SYSTEM) |
|---|---|---|
| K-numbers | N/A (Comparison to specific K-numbers of predicates) | K041655 |
| Proprietary Name | Brånemark System® / 3i Restorative Dental Implant Systems | BioPlant System |
| CFR Section | 872.3640 | SAME |
| Pro-code | DZE & NHA | SAME |
| Classification Name | Endosseous Dental Implant and Abutment Device | SAME |
| Indications for Use | Functionally equivalent to predicates (e.g., for single/two-stage procedures, cement/screw retained restorations, integration with bone, immediate placement in specific bone types, anchor for prosthetic devices). | "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." |
| Design (Implants) | Threaded, self-tapping, external hex, root-form | SAME (Threaded, self tapping, external hex, root-form) |
| Diameter (Implants) | Predicates: 3.3 - 5.0 mm (Nobel Biocare), 3.25 - 6.0 mm (3i) | 3.3 - 6.0 mm |
| Length (Implants) | 7.0 - 18 mm | SAME (7.0 - 18 mm) |
| Material (Implants) | Commercially pure (CP) titanium (Ti) | SAME (Commercially pure (CP) titanium (Ti)) |
| Coating (Implants) | Non-coated and Coated (HA) | Non-coated |
| Surface Finish | Machined or roughened / textured (via proprietary roughening method). Transmucosal part smooth machined finish. | Machined or roughened / textured (abrasive blasted). If roughened, the transmucosal part maintains a smooth machined finish to allow for the attachment of epithelial tissue. (Described as EQUIVALENT to predicates) |
| Design (Abutments) | Equivalent, including angled and universal abutments. | Abutments (straight, no angle): healing, cemented and non-cemented / screw attached. Miniscone, Estheticone, temporary and UCLA type, with associated cylinder and coping screws. (Described as EQUIVALENT to predicates, though predicates also include angled and universal abutments). This implies similarity in core functionality but not necessarily exact replication of all predicate types. |
| Materials (Abutments) | CP Ti, Ti alloy, gold alloy, (Nobel Biocare also Ceramic, 3i also Plastic) | CP Ti, Ti alloy, or gold alloy |
| Materials (Screws) | CP Ti, Ti alloy, or gold alloy | SAME |
| Color additives | No color additives used. | SAME |
| Accessories available | EQUIVALENT to point, twist, tap, pilot, countersink, hand-driver, machine driver, mount driver. | point, twist, tap, pilot, countersink, hand-driver, machine driver, mount driver (Described as EQUIVALENT to predicates) |
| Provided Sterile? | YES | YES |
| Sterilization Method(s) | Various Methods | Irradiation, SAL 10-6 |
| Packaging (Implants) | Glass ampul in peel-open blister pack (Nobel Biocare) / Heat sealed peel-open nylon pouch (3i) | Polymeric ampul in peel-open blister pack |
| Packaging (Abutments) | EQUIVALENT to various methods | Various methods (Described as EQUIVALENT to predicates) |
| Contraindications | Functionally equivalent to standard contraindications for dental implants (e.g., insufficient jawbone, poor bone quality, poor oral hygiene, heavy smoking/tobacco abuse, medical conditions like blood disorders/uncontrolled diabetes, general oral surgical procedure unfitness). | "Bio Plant System implants should not be placed in patients where the retaining jawbone is too diminished to provide adequate width or height to surround the implant. Failure to osseointegration or subsequent loss of osseointegration may occur in cases where there is insufficient available bone, poor bone quality, poor oral hygiene, heavy smoking or tobacco abuse, or medical conditions such as blood disorders or uncontrolled diabetes." Also lists possible and temporary contraindications, and anatomical/pathological contraindications. (Described as FUNCTIONALLY EQUIVALENT to predicates). |
| Precautions/Warnings | Functionally equivalent to general precautions and warnings for dental implant procedures (e.g., proper technique, acknowledging contraindications, no modification of components, use only designated components, risk of failure/harm). | "Content of the precaution and warning sections for the (IFU) package insert generally refer to the need for practitioners to lean and employ proper technique, to appropriately acknowledge contraindications, not to modify any components or instrumentation, to utilized only components and instrumentation designated by the manufacturer and that failure to observe cautions and warnings could result in failure of the procedure and or harm to the patient." (Described as FUNCTIONALLY EQUIVALENT to predicates). |
| Mechanical Fatigue | Similar testing performed and similar outcomes achieved by predicate devices (implied that devices withstand expected forces and cycles). | "Mechanical fatigue testing under shear force with a 25kg load, and static shear testing was performed to establish the mechanical properties of the BioPlant System and to confirm fixture/implant-abutment compatibility. ... Assembled implant-abutment samples were subjected to 5 million cycles (2-14 Hz) under shear forces with 25kg loads applied 30° off the center axis of the implant-abutment system. All samples survived. Assembled implant-abutment samples were also subjected to static shear testing to establish the yield point of the fixture and abutment fixed with a screw. All samples exhibited acceptable yield points and no fractures or crack occurred prior to yield." |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set (Non-clinical): For the mechanical fatigue and static shear testing, the document states: "BioPlant System production unit implant-abutment system samples, considered physically representative of the design most prone to worst-case mechanical loading following implantation, were subjected to testing per part 5 of ISO 14801."
- The exact sample size (number of units tested) is not explicitly stated in the provided text, beyond "All samples survived" and "All samples exhibited acceptable yield points."
- Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly. Given that the manufacturer is Cowell Medi Co., Ltd. from Busan, Korea, it's reasonable to infer the testing was likely conducted in Korea or by an accredited lab on behalf of the manufacturer. The testing adheres to ISO 14801, an international standard. The data is prospective in the sense that custom tests were performed on the BioPlant System samples to demonstrate performance against established standards.
-
Test Set (Clinical): No new clinical test set was used for the BioPlant System itself. The submission explicitly states: "Cowell Medi perceives the adequacy of such existing documentation substantiates the exclusion of both animal and human clinical studies protocols or data." Instead, they rely on "Abundant, significant, peer reviewed documentation supporting the successful clinical performance of root-form endosseous dental implants and abutment systems exists." This refers to retrospective evidence from the wider body of literature and the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Non-clinical Testing: For the mechanical and static shear testing, ground truth is established by objective engineering standards (ISO 14801) and the physical properties of the materials and design, not by expert consensus. There are no "experts" establishing unique ground truth in this context; rather, the tests measure objective performance metrics.
- Clinical Ground Truth: No new clinical ground truth was established by experts for the BioPlant System specifically. The submission relies on existing "peer-reviewed documentation" and the clinical history of the predicate devices. The "ground truth" for clinical performance, in this case, is derived from the established safety and effectiveness of similar devices in the medical literature.
4. Adjudication Method for the Test Set
- Non-clinical Testing: Not applicable. The mechanical and static shear tests have objective pass/fail criteria (e.g., survival after 5 million cycles, acceptable yield points, no fractures prior to yield). There's no human adjudication of ambiguous results.
- Clinical Testing: Not applicable, as no new clinical studies were performed.
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. The document describes a dental implant system, not a diagnostic AI device requiring multi-reader, multi-case studies or assessment of human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Non-clinical: Objective physical and mechanical standards (ISO 14801), laboratory measurements of fatigue resistance and yield strength.
- Clinical: The clinical ground truth for showing "successful osseointegration" and "firm and direct connection between the living bone and surface of the titanium implant" is based on the general body of "Abundant, significant, peer reviewed documentation" for root-form endosseous dental implants. This implies reliance on historical outcomes data and expert consensus within the dental community regarding the performance of similar, established devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device requiring a training set. The device design and manufacturing processes are likely informed by years of engineering knowledge and clinical experience with dental implants, rather than a quantifiable training dataset in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI device.
{0}------------------------------------------------
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 : 82-51-896-2554 TEL : 82-51-644-2028, 896-2877, 896-2553 Eactory Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea FAX : 82-51-314-2026 TEL : 82-51-314-2028, 316-2027
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. 603 373 0260 Cowell Medi Co., Ltd. Manufacturer: Cowell Medi Co., Ltd.
Dongju Bldg. 2F., 45-3, Gaya 1 Dong, Busanjin-Gu, Busan, 614-800, Korea Tel: 82-51-896-2877 / 82-51-314-2028 Fax.: 82-51-896-2554 / 82-51-314-2026 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
{1}------------------------------------------------
OWER MEDI
Head office
ADDRESS : Dong-ju Bldg 2F 45-5, . . .ya-IDong, BusanJin-Gu, Busan, Korea
TEL : 82-51-644-2028, 896-2877, 896-2553 Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
TEL : 82-51-314-2028, 316-2027
able, 510(k) Summary per 21 CFR 807.92: Predicate Device(s) Compariso
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
|---|---|---|---|
| "K" numbers | K | K925777, K925779, K961728, K971706,K974140 K992937, K993595, K022562 | K983347, K965077, K934126, K935544,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 formendosseous dental implants and compatibleimplant abutment systems. BioPlant Systems aredesigned for use in dental implant surgery andare intended to be used in a manor in which they(the implants) integrate with the bone(osseointegration). The BioPlant abutmentsystems include various abutments designed toenable the implant process from healing thrufinal restoration. Clinical studies havedemonstrated that, when surgically implantedhinder controlled conditions. a successfullyosseointegrated implant will achieve a firm anddirect connection between the living bone andsurface of the titanium implant. BioPlant | (Functionally the same)Brånemark System implants are for single-stageor two-stage surgical procedures and cement orscrew retained restorations. The BrånemarkSystem implants are intended for immediateplacement and function on single tooth and ormultiple tooth applications recognizingsufficient bone stability (type I or II bone) andappropriate occlusal loading, to restore chewingfunctions. Multiple applications may be splintedwith a bar. The Brånemark Abutments System isa set of cemented or screw retained preparableabutments which are secured to an endosseousimplant and is intended to function as an anchorto which prosthetic devices, such as artificial | (Functionally the same)3i Dental Implant Systems are indicated forsurgical placement in the upper or lower jaw toprovide a means for prosthetic attachment torestore a patients chewing function. Abutmentsand accessories are indicated for use in surgicaland restorative applications when placing dentalimplants. |
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Continued:Intended / Indications for use: | implants are for single or two-stage surgicalprocedures. Bio Plant Systems are intended forimmediate placement in partially or fullyedentulous mandibles and maxillae (type I or IIbone), in support of single or multiple-unitrestorations including; cement retained. screwretained, or over-denture restorations. andterminal or intermediate abutment support forfixed bridgework. Multiple tooth applicationsmay be splinted with a bar. | teeth. may be attached using dental cement torestore 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 (abrasiveblasted). If roughened. the transmucosal partmaintains a smooth machined finish to allow forthe attachment of epithelial tissue. | EQUIVALENT: Machined or roughened/textured via proprietary roughening method. Ifroughened, the transmucosal part maintains asmooth machined finish to allow for theattachment of epithelial tissue. | EQUIVALENT: Machined or roughened/textured via proprietary roughening method. Ifroughened, the transmucosal part maintains asmooth machined finish to allow for theattachment of epithelial tissue. |
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Design -(Abutments) | Abutments (straight, no angle): healing,cemented and non-cemented / screw attached.Miniscone. Estheticone. temporary and UCLAtype, with associated cylinder and copingscrews. | EQUIVALENT: but also include angled anduniversal abutments | EQUIVALENT: but also include angled anduniversal 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 &Abutments) | There are no color additives used in any of thematerials of the components of the device. | SAME | SAME |
| Accessories available - drillsDrivers: | point, twist. tap. pilot, countersink. hand-driver.machine driver, mount driver | EQUIVALENT | EQUIVALENT |
| Provided Sterile? - (Implants& 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 /screws) | Various methods | EQUIVALENT | EQUIVALENT |
| Contraindications (fromInstructions for use (IFU)package insert labeling) | Bio Plant System implants should not be placedin patients where the retaining jawbone is toodiminished to provide adequate width or heightto surround the implant. Failure to | FUNCTIOALLY EQUIVALENT: (from IFU)Pre-operative patient evaluation is necessary todetermine any factors which put the patient riskfrom the implant placement procedure itself of | FUNCTIOALLY EQUIVALENT: (from 510(k)Summary) Implants should not be used in caseswhere the remaining jawbone is too diminishedto provide adequate width or height to surround |
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Continued:Contraindications (fromInstructions for use (IFU)package insert labeling) | osseointegration or subsequent loss ofosseointegration may occur in cases where thereis insufficient available bone, poor bone quality,poor oral hygiene, heavy smoking or tobaccoabuse, or medical conditions such as blooddisorders or uncontrolled diabetes. | factors that may effect healing capacities ofeither the bone or associated soft tissue. Dentalimplants should not be used in patients who areunfit medically for a general oral surgicalprocedure. For patients who have local ofsystemic factors which could be expected tointerfere with the healing process of either boneor soft tissue (e.g. connective tissue disorders,steroid therapy, infections in bone, cigarettesmoking) the potential benefits and risks oftreatment need to be carefully evaluated. | the implant. Lack of osseointegration orsubsequent implant failure may occur in caseswhere there is insufficient available bone orpoor bone quality, poor oral hygiene, heavysmoking or tobacco abuse, or medicalconditions such as blood disorders, infection(s),vascular impairment at surgical site. |
| Contraindications associated with electivesurgery should be observed. | In addition, the patients need to have anadequate volume of residual bone for placingsufficient size and numbers of implants tosupport the anticipated functional loads thepatient will subject these implants to. | uncontrolled diabetes, heavy smoking ortobacco abuse, drug or alcohol abuse, chronichigh dose steroid therapy, medical conditionssuch as blood clotting disorders, current orongoing anticoagulant therapy, metabolic bonedisease or other metabolic or systemic disorderswhich may adversely affect bone or woundhealing or cases in which the available bone istoo diminished to provide adequate width orheight to adequately hold implants andrestorative appliances. | |
| Possible contraindications: Chronic bleedingproblem; psychological impairment; metabolicbone or connective tissue diseases; treatmentwith corticosteroids; certain cardiac andvascular diseases; tobacco usage diabetes(uncontrolled); treatment with chemotherapeuticagent; chronic renal disease; poor patient oralhygiene; bruxing, alcoholism. | Insufficient size or numbers of implants tosupport biomechanical loads or undesirablepositioning of the implants can lead tomechanical failure including fatigue fracture ofimplants, prosthetic screws or abutment screws. | ||
| Temporary contraindications: Systemicinfection; local oral or respiratory infection. | Implant placement and prosthetic design mustaccommodate individual patient conditions such | ||
| Anatomical or pathological contraindications:Insufficient alveolar bone width and height tosurround the implant with at least onemillimeter of bone, both buccally and linguallyto the most superior aspect of the implant | |||
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Continued:Contraindications (fromInstructions for use (IFU)package insert labeling) | placement would encroach on the mandibularcanal: malignancies. | as bruxism or unfavorable jaw relationships toreduce the risk of overload or fatigue failure.and treatment is contraindicated if adequateaccommodation cannot be accomplished. Ifinadequate bone volume is presentaugmentation procedures can be considered.Please consult appropriate surgical andrestorative manuals and textbooks forinformation on treatment planning and medicalevaluation. | |
| Precautions and Warningsfrom instructions for use(IFU) package insert labeling) | Content of the precaution and warning sectionsfor the (IFU) package insert generally refer tothe need for practitioners to lean and employproper technique, to appropriately acknowledgecontraindications. not to modify anycomponents or instrumentation, to utilized onlycomponents and instrumentation designated bythe manufacturer and that failure to observecautions and warnings could result in failure ofthe procedure and or harm to the patient. | FUNCTIOALLY EQUIVALENT toprecautions and warnings provided in (IFU)package insert labeling. | FUNCTIOALLY EQUIVALENT: Actual IFUlabeling was unavailable at the time of this510(k) submission however 3i's on-line surgicalmanual provides functionally equivalentinformation. |
| Non-clinical testingperformed: | Though the Cowell Medi implant and abutmentdesigns and technology characteristics are not | 510(k) summaries available for BranemarkSystem suggest that similar testing was | 510(k) summaries available for 3i DentalImplant Systems suggest that similar testing was |
| ATTRIBUTE / CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Continued:Non-clinical testingperformed: | significantly different from the predicate devices to which substantial equivalency is sought, mechanical fatigue testing under shear force with a 25kg load, and static shear testing was performed to establish the mechanical properties of the BioPlant System and to confirm fixture/implant-abutment compatibility: BioPlant System production unit implant-abutment system samples, considered physically representative of the design most prone to worst-case mechanical loading following implantation, were subjected to testing per part 5 of ISO 14801. Assembled implant-abutment samples were subjected to 5 million cycles (2-14 Hz) under shear forces with 25kg loads applied 30° off the center axis of the implant-abutment system. All samples survived. Assembled implant-abutment samples were also subjected to static shear testing to establish the yield point of the fixture and abutment fixed with a screw. All samples exhibited acceptable yield points and no fractures or crack occurred prior to yield. Protocols and results are provided | performed and similar outcomes achieved. | performed and similar outcomes achieved. |
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3I) |
| Continued:Non-clinical testingperformed: | in section 13 of this submission. | ||
| Clinical data / performancetesting: | Abundant, significant, peer revieweddocumentation supporting the successful clinicalperformance of root-form endosseous dentalimplants and abutment systems exists. TheCowell Medi implants and abutment systems(BioPlant Systems) that are the subject of this510(k) submission are substantially equivalentin design, technology and labeling to many ofthe devices identified in the aforementioneddocumentation, including but not limited to thelegally marketed predicate devices identified inthis submission. Cowell Medi perceives theadequacy of such existing documentationsubstantiates the exclusion of both animal andhuman clinical studies protocols or data. | ||
| ATTRIBUTE /CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM(Submitted Product) | LEGALLY MARKETED PREDICATEDEVICES OFNobel Biocare USA & AB | LEGALLY MARKETED PREDICATEDEVICES OFImplant Innovations, Inc. (3i) |
| Additional Information | |||
| Class II Special Controls | 510(k) for Cowell Medi BioPlant System | ||
| Guidance Document: Root- | submitted in accordance with content of Special | ||
| form Endosseous Dental | Controls Guidance Document: Root-form | ||
| Implants and Abutments; | Endosseous Dental Implants | ||
| Draft Guidance for Industry | |||
| d FDA |
Section 5: Page 2 of
Plant System 510(k) Summary per 21 CFR 807
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for Cowell Medi. The logo is vertically oriented with the text "COWELL MEDI" stacked on top of each other. To the right of the logo is the text "Bio Plant System".
Head office
ADDRESS : Dong-ju Bldg 2F 43-3, .. . .ya-1Dong, BusanJin-Gu, Busan, Korea
TEL : 82-51-644-2028, 896-2877, 896-2553
Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
TEL : 82-51-314-2028, 316-2027
oPlant System 510(k) Summary per 21 CFR 807.92
{3}------------------------------------------------
Image /page/3/Picture/9 description: The image shows the logo for WELL MEDI Bio Plant System. The text "WELL MEDI" is stacked vertically and rotated 90 degrees counter-clockwise. The words "Bio Plant System" are to the right of "WELL MEDI" and are stacked vertically.
Head office
ADDRESS : Dong-ju Bldg 2F 45-3,
Factory
ADDRESS : 565-12, Gwacbeob-Dong, Sasang-Gu, Busan, Korea
TEL : 82-51-314-2028, 316-2027
ODRESS: 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
EL: 82-51-314-2028, 316-2027
FAX: 82-51-314-202-
ection 5: Page 4 of
oPlant System 510(k) Summary per 21 CFR 807
{4}------------------------------------------------
Image /page/4/Picture/4 description: The image shows the logo for "Gower Medi Bio Plant System". The logo is vertically oriented with the text "Gower Medi" stacked on top of each other. The words "Bio Plant System" are to the right of "Medi".
Head office
ADDRESS : Dong-ju Bldg 2F 43-3, . ...ya-1Dong, BusanJin-Ou, Busan, Korea
TEL : 82-51-644-2028, 896-2877, 896-2553 FAX : 82-51-896-2554 Factory
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
TEL : 82-51-314-2028, 316-2027
{5}------------------------------------------------
Image /page/5/Picture/7 description: The image shows the logo for OWEL MEDI Bio Plant System. The logo is vertically oriented with the text "OWEL MEDI" stacked on top of each other. The text "Bio Plant System" is to the right of the stacked text. A curved line wraps around the left side of the text.
Head office
ADDS : 2018-ju Bldg 28 43-3. - 37-3. : 37-3. : 37-3. : 32-3. : 32-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 35-3. : 31-3. : 4-2
ection 5: Page 6 of
oPlant System 510(k) Summary per 21 CFR 801
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Cowell Medi. The logo is vertically oriented with the text "COWELL" stacked on top of "MEDI". To the right of the text is the phrase "Bio Plant System", also vertically oriented. A curved line extends from the bottom of the "C" in "COWELL" to the top of the "I" in "MEDI", encircling the text.
Head office
ADD BRSS : (448-3148, 896-2877, 896-2333
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Cowell Medi Bio Plant System. The logo is vertically oriented with the text "COWELL MEDI" stacked on top of each other. Below the text is "Bio Plant System" in a smaller font size. The logo is in black and white.
. Out office
ADL: 32-S S : Dong-ju Bldg 2F 45-3, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
oPlant System 510(k) Summary per 21 CFR 807
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for "COMEDI Bio Plant System". The logo is vertically oriented with the text "COMEDI" in a stylized font. To the right of the logo is the text "Bio Plant System" in a smaller, simpler font.
ADDRESS : 565-12, Gwaebeob-Dong, Sasang-Gu, Busan, Korea
TEL : 82-51-314-2028, 316-2027 - - - - - FAX : 82-51-314-2026 Head office
ADDRESS : Dong-ju Bldg 2F 45-3, 2 -34-1 Dong, BusanJin-Ou, Busan
TEL : 82-51 -644-2028, 896-2877, 896-2553
ttp://www.cowellmedi.com
beling for same, the Covell Medi BioPlant System endosseous dental implants, abutments and accessories are substantially equivalent nclusion: Based on a review of available 510(k) summaries for product codes DZE (implants) and a review of availah ike devices legally marketed by Nobel Biocare (Brand) and 3) Implant Innovations, Inc. (3) Restorative Dental Implant System
··············································································································································································
10(k) Summary per 21 CFR 807. -- End --
ี่
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three curved lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Cowell Medi, Company Limited C/O Mr. Martin J. Leighton Regulatory Affairs Quality Assurance, International, LLC 161 Little Bay Road Newington, New Hampshire 03801
Re: K041655
Trade/Device Name: BioPlant System (Implants and Abutments) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 16, 2004 Received: June 18, 2004
Dear Mr. Leighton:
We have reviewed your Section 510(k) premarket notification of intent to market the device ve for of obove and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 Amendinentel, or to as read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wr ), it may of cash of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or router announcements concerning your device in the Federal Register.
{10}------------------------------------------------
Page 2 - Mr. Leighton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements moan that i Dr mas made a statutes and regulations administered by other Federal agencies. or the receir any - outh all the Act's requirements, including, but not limited to: registration 1 od Intiles compry was 807); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet ronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This feter will as a .. The FDA finding of substantial equivalence of your device to a premarket notified.com of a 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), If you desire specifics of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Indications for Use Statement Section 4:
| 510(k) Number | K 041655 |
|---|---|
| Applicant: | Cowell Medi Company, Ltd. |
| Device Name | BioPlant System |
| Indicationsfor Use | BioPlant Systems refer to sets of root form endosseous dental implantsand compatible implant abutment systems. BioPlant Systems aredesigned for use in dental implant surgery and are intended to be usedin a manor in which they (the implants) integrate with the bone(osseointegration). The BioPlant abutment systems include variousabutments designed to enable the implant process from healing thrufinal restoration. Clinical studies have demonstrated that, whensurgically implanted under controlled conditions, a successfullyosseointegrated implant will achieve a firm and direct connectionbetween the living bone and surface of the titanium implant. BioPlantimplants are for single or two-stage surgical procedures. Bio PlantSystems are intended for immediate placement in partially or fullyedentulous mandibles and maxillae (type I or II bone), in support ofsingle or multiple-unit restorations including; cemented retained, screwretained, or over-denture restorations, and terminal or intermediateabutment support for fixed bridgework. Multiple tooth applications maybe splinted with a bar. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801. 109) | X |
|---|---|
| OR | Over-The-Counter Use |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K041655 |
|---|---|
| ---------------- | --------- |
Cowell Medi 510(k)
Bio Plant System
Section 4: Page 1 of 1
§ 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.