KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK

K080224 · SOADCO, S.L. · DZE · Jul 3, 2008 · Dental

Device Facts

Record IDK080224
Device NameKLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
ApplicantSOADCO, S.L.
Product CodeDZE · Dental
Decision DateJul 3, 2008
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Indications for Use

The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height. The Essential Cone implants are fitted with an internal octagonal conical connection. The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants. Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations. 8mm Implants are not indicated for use as unitary implants and for immediate load.

Device Story

Klockner Essential implant system consists of endosseous dental implants and accessories; used to replace tooth roots and support dental prosthetics. Implants feature internal octagonal conical connections (with or without external octagonal connection). Diameters range 3.5mm-4.8mm; lengths 8mm-16mm. Surgical insertion performed by dental professionals. Immediate loading permitted given sufficient primary stability and appropriate occlusal loading. System provides structural support for single or multiple tooth restorations. Benefits include restoration of masticatory function.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, material, and intended use similarity to predicate devices.

Technological Characteristics

Endosseous dental implants; materials not specified; internal octagonal conical connection; diameters 3.5mm, 4.0mm, 4.8mm; lengths 8mm-16mm. Mechanical device; no software or energy source.

Indications for Use

Indicated for surgical insertion into bone to replace tooth roots and support dental restorations. 3.5mm implants recommended for hard/compact bone (D1-D2); 4.0mm implants for soft/cancellous bone (D3-D4); 4.8mm implants for molar replacement and immediate placement. 8mm implants contraindicated for unitary use and immediate loading.

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

Submission Summary (Full Text)

{0}------------------------------------------------ K080.224 JUL - 3 2008 Image /page/0/Picture/2 description: The image shows the text "ASOAD" in a stylized font. The letters are large and bold, with a textured pattern that gives them a three-dimensional appearance. There is also a logo with the text "KLOCKNER" in a smaller font. The overall design is eye-catching and appears to be a logo or branding element. # PREMARKED NOTIFICATION [510 (K)] SUMMARY - 1. IDENTIFICATION - 2. DEVICE NAME - 3. PREDICATE DEVICE - 4. DESCRIPTION - 5. INTENDED USE - 6. BASIS FOR SUBSTANTIAL EQUIVALENCE {1}------------------------------------------------ K080224 Image /page/1/Picture/1 description: The image shows the text "SOAD" in a stylized, blocky font. The letters are large and bold, with a textured, pixelated effect. The letters are arranged horizontally, with the "O" containing a graphic of a skull-like figure. Below the skull is the text "SKYLOCKING". # 1. IDENTIFICATION - Denomination: KLOCKNER dental implants - Manufacturer name and address: SOADCO, S.L. Avgda. Fiter i Rossell, 4bis - Local 2 ESCALDES - ENGORDANY AD-700 (ANDORRA) - Contact person: Maria Mitjaneta - Telephone and Fax numbers: (376) 800 590 / Fax- (376) 800 594 - Date: 06/03/08 ## 2. DEVICE NAME TRADE NAME: KLOCKNER essential dental implants system models Essential Cone (EC), Essential Solid (ES), ECK. COMMON NAME: Dental endosseous implant CLASSIFICATION NAME: Endosseous implant (21 CFR 872.3640) Endosseous dental implant abutment (21 CFR 872.3630) # 3. PREDICATE DEVICE / LEGALLY MARKETED DEVICE NAME: Dental endosseous implant #### LEGALLY MARKETED DEVICE: Klockner dental implants models S3M (K052654) SK2, NK2, S4, S6 (K010132) Straumann RN Dental implants (K033922) (K030007) (K07188) (K062129) (K041295) (K070549) (K962023) (K071585) (K994119) (K063789) (K033243) 3i Dental Implants (K030614) (K072363) {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters "ASOAD" in a bold, stylized font. The letters are arranged horizontally, with some overlapping. The letter "C" has a graphic of a frog on it. Below the frog is the word "Klockner" in a smaller font. ## 4. DESCRIPTION The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected. ## 5. INTENDED USE OF THE DEVICE The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height. The Essential Cone implants are fitted with an internal octagonal conical connection. The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants. Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. #### Indications: · The 3.5mm Ø ESSENTIAL® implants are recommended for fitting in hard or compact bones [D1-D2 bone type], such as the lower jaw. · The 4.0mm Ø ESSENTIAL® implants are recommended for fitting in soft or cancellous bones [D3-D4 bone type], such as the upper maxillary. · The 4.8mm Ø ESSENTIAL® implants are recommended for the replacement of molars and for fitting immediate implants. #### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE The subject implants and abutments are substantially equivalent to the previously cleared Klockner dental implants system cleared in K010132 and K052654 because the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 UUL - 8 2008 Ms. Maria Mitjaneta Quality Assurance Manager SOADCO. S.L. Avgda, Fiter I Rossell 4 Bis Local 2 Escaldes-Engordany ANDORRA AD - 700 Re: K080224 Trade/Device Name: Klockner Essential Implant System Models Essential Cone (EC), Essential Solid (ES), ECK Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 3, 2008 Received: June 6, 2008 Dear Ms. Mitjaneta: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Ms. Mitjaneta 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. 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 Division 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. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### 510(k) Number (if known): K080224 ## Device Name: KLOCKNER ESSENTIAL IMPLANT SYSTEM MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES), ECK #### Indications For Use: The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height. The Essential Cone implants are fitted with an internal octagonal conical connection. The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants. Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations. 8mm Implants are not indicated for use as unitary implants and for immediate load. Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use Abbetz DDS for Dr. Susan Runner (Division Sign-Off) レ Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K080224
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