(82 days)
No
The summary describes a system of dental implants and abutments, focusing on their materials, dimensions, intended use in surgery, and mechanical testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device replaces missing teeth and provides a stable foundation for restorations, thus treating a condition (missing teeth) and restoring function.
No
The device, BioPlant Systems, is a set of dental implants and abutments designed for surgical implantation to replace teeth and provide a foundation for restorations. Its intended use is therapeutic (replacement of anatomical structures), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states that the Bio Plant System includes physical components such as "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." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to be placed within the human body (jawbone) to support dental restorations. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the physical components of the implant and abutment system, their materials, and how they are used in a surgical procedure. There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of Diagnostic Function: The device's purpose is to provide a stable foundation for teeth, not to diagnose a disease or condition.
- Performance Studies: The performance studies focus on mechanical properties and compatibility, which are relevant to the structural integrity and function of an implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE & NHA
Device Description
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 (implants) or biocompatible, wrought titanium or gold alloy (accessory fixtures). The implants are available with either smooth (bright) or textured (abrasive blasted) surface finish. Implants range from 7.0 mm to 18 mm in length. The implants are intended to be surgically inserted into the upper and/or lower jawbone to serve as a substitute or replacement tooth and provide a stable and firm foundation for restorations. Drill sequences, instruments and insertion instruments, as well as screws are specified and available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and/or lower jawbone, mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Though the Cowell Medi implant and abutment designs and technology characteristics are not 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 in section 13 of this submission.
Clinical data / performance testing: Abundant, significant, peer reviewed documentation supporting the successful clinical performance of root-form endosseous dental implants and abutment systems exists. The Cowell Medi implants and abutment systems (BioPlant Systems) that are the subject of this 510(k) submission are substantially equivalent in design, technology and labeling to many of the devices identified in the aforementioned documentation, including but not limited to the legally marketed predicate devices identified in this submission. Cowell Medi perceives the adequacy of such existing documentation substantiates the exclusion of both animal and human clinical studies protocols or data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K925777, K925779, K961728, K971706, K974140, K992937, K993595, K022562
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K983347, K965077, K934126, K935544, K022009, K022113
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant 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 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
hinder controlled conditions. a successfully
osseointegrated implant will achieve a firm and
direct connection between the living bone and
surface of the titanium implant. BioPlant | (Functionally the same)
Brånemark System implants are for single-stage
or two-stage surgical procedures and cement or
screw retained restorations. The Brånemark
System implants are intended for immediate
placement and function on single tooth and or
multiple tooth applications recognizing
sufficient bone stability (type I or II bone) and
appropriate occlusal loading, to restore chewing
functions. Multiple applications may be splinted
with a bar. The Brånemark Abutments System is
a set of cemented or screw retained preparable
abutments which are secured to an endosseous
implant and is intended to function as an anchor
to which prosthetic devices, such as artificial | (Functionally the same)
3i Dental Implant Systems are indicated for
surgical placement in the upper or lower jaw to
provide a means for prosthetic attachment to
restore a patients chewing function. Abutments
and accessories are indicated for use in surgical
and restorative applications when placing dental
implants. |
| ATTRIBUTE /
CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3i) |
| Continued:
Intended / Indications for use: | 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; cement 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. | teeth. may be attached using dental cement to
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
blasted). If roughened. the transmucosal part
maintains a smooth machined finish to allow for
the attachment of epithelial tissue. | EQUIVALENT: Machined or roughened
/textured via proprietary roughening method. If
roughened, the transmucosal part maintains a
smooth machined finish to allow for the
attachment of epithelial tissue. | EQUIVALENT: Machined or roughened
/textured via proprietary roughening method. If
roughened, the transmucosal part maintains a
smooth machined finish to allow for the
attachment of epithelial tissue. |
| ATTRIBUTE /
CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3i) |
| Design -(Abutments) | Abutments (straight, no angle): healing,
cemented and non-cemented / screw attached.
Miniscone. Estheticone. temporary and UCLA
type, with associated cylinder and coping
screws. | EQUIVALENT: but also include angled and
universal abutments | EQUIVALENT: but also include angled and
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 &
Abutments) | There are no color additives used in any of the
materials of the components of the device. | SAME | SAME |
| Accessories available - drills
Drivers: | 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 (from
Instructions for use (IFU)
package insert labeling) | 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 | FUNCTIOALLY EQUIVALENT: (from IFU)
Pre-operative patient evaluation is necessary to
determine any factors which put the patient risk
from the implant placement procedure itself of | FUNCTIOALLY EQUIVALENT: (from 510(k)
Summary) Implants should not be used in cases
where the remaining jawbone is too diminished
to provide adequate width or height to surround |
| ATTRIBUTE /
CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3i) |
| Continued:
Contraindications (from
Instructions for use (IFU)
package insert labeling) | 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. | factors that may effect healing capacities of
either the bone or associated soft tissue. Dental
implants should not be used in patients who are
unfit medically for a general oral surgical
procedure. For patients who have local of
systemic factors which could be expected to
interfere with the healing process of either bone
or soft tissue (e.g. connective tissue disorders,
steroid therapy, infections in bone, cigarette
smoking) the potential benefits and risks of
treatment need to be carefully evaluated. | the implant. Lack of osseointegration or
subsequent implant failure may occur in cases
where there is insufficient available bone or
poor bone quality, poor oral hygiene, heavy
smoking or tobacco abuse, or medical
conditions such as blood disorders, infection(s),
vascular impairment at surgical site. |
| | Contraindications associated with elective
surgery should be observed. | In addition, the patients need to have an
adequate volume of residual bone for placing
sufficient size and numbers of implants to
support the anticipated functional loads the
patient will subject these implants to. | uncontrolled diabetes, heavy smoking or
tobacco abuse, drug or alcohol abuse, chronic
high dose steroid therapy, medical conditions
such as blood clotting disorders, current or
ongoing anticoagulant therapy, metabolic bone
disease or other metabolic or systemic disorders
which may adversely affect bone or wound
healing or cases in which the available bone is
too diminished to provide adequate width or
height to adequately hold implants and
restorative appliances. |
| | Possible contraindications: Chronic bleeding
problem; psychological impairment; metabolic
bone or connective tissue diseases; treatment
with corticosteroids; certain cardiac and
vascular diseases; tobacco usage diabetes
(uncontrolled); treatment with chemotherapeutic
agent; chronic renal disease; poor patient oral
hygiene; bruxing, alcoholism. | Insufficient size or numbers of implants to
support biomechanical loads or undesirable
positioning of the implants can lead to
mechanical failure including fatigue fracture of
implants, prosthetic screws or abutment screws. | |
| | Temporary contraindications: Systemic
infection; local oral or respiratory infection. | Implant placement and prosthetic design must
accommodate individual patient conditions such | |
| | Anatomical or pathological contraindications:
Insufficient alveolar bone width and height to
surround the implant with at least one
millimeter of bone, both buccally and lingually
to the most superior aspect of the implant | | |
| ATTRIBUTE /
CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3i) |
| Continued:
Contraindications (from
Instructions for use (IFU)
package insert labeling) | placement would encroach on the mandibular
canal: malignancies. | as bruxism or unfavorable jaw relationships to
reduce the risk of overload or fatigue failure.
and treatment is contraindicated if adequate
accommodation cannot be accomplished. If
inadequate bone volume is present
augmentation procedures can be considered.
Please consult appropriate surgical and
restorative manuals and textbooks for
information on treatment planning and medical
evaluation. | |
| Precautions and Warnings
from instructions for use
(IFU) package insert labeling) | 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. | FUNCTIOALLY EQUIVALENT to
precautions and warnings provided in (IFU)
package insert labeling. | FUNCTIOALLY EQUIVALENT: Actual IFU
labeling was unavailable at the time of this
510(k) submission however 3i's on-line surgical
manual provides functionally equivalent
information. |
| Non-clinical testing
performed: | Though the Cowell Medi implant and abutment
designs and technology characteristics are not | 510(k) summaries available for Branemark
System suggest that similar testing was | 510(k) summaries available for 3i Dental
Implant Systems suggest that similar testing was |
| ATTRIBUTE / CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3i) |
| Continued:
Non-clinical testing
performed: | 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 PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant Innovations, Inc. (3I) |
| Continued:
Non-clinical testing
performed: | in section 13 of this submission. | | |
| Clinical data / performance
testing: | Abundant, significant, peer reviewed
documentation supporting the successful clinical
performance of root-form endosseous dental
implants and abutment systems exists. The
Cowell Medi implants and abutment systems
(BioPlant Systems) that are the subject of this
510(k) submission are substantially equivalent
in design, technology and labeling to many of
the devices identified in the aforementioned
documentation, including but not limited to the
legally marketed predicate devices identified in
this submission. Cowell Medi perceives the
adequacy of such existing documentation
substantiates the exclusion of both animal andhuman clinical studies protocols or data. | | |
| ATTRIBUTE /
CHARACTERISTIC | COWELL MEDI BIOPLANT SYSTEM
(Submitted Product) | LEGALLY MARKETED PREDICATE
DEVICES OF
Nobel Biocare USA & AB | LEGALLY MARKETED PREDICATE
DEVICES OF
Implant 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
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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
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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
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10(k) Summary per 21 CFR 807. -- End --
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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.
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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
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Indications for Use Statement Section 4:
| 510(k) Number | K 041655 |
|---|---|
| Applicant: | Cowell Medi Company, Ltd. |
| Device Name | BioPlant System |
| Indications | |
| for 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. |
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