(296 days)
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.
Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in:
- Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system.
- Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system.
- Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system.
- Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system.
- Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System.
- Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system.
Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.
This is a 510(k) premarket notification for KLOCKNER Dental Implant Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML device.
Therefore, many of the requested points, particularly those related to AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets, cannot be extracted from this document because they are not applicable to the type of device and submission presented.
Here's an analysis of the provided text based on the questions, noting where information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or device performance metrics for a novel device in the way a clinical study for an AI/ML device would. The submission aims to establish "substantial equivalence" based on similar materials, design, and intended use to existing predicate devices.
The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons to predicate devices and bench testing.
- Bench Testing: The document states, "The results of bench testing confirm acceptable device performance as per its intended use." Specific performance values or acceptance criteria for these bench tests (e.g., torsion, fatigue testing according to ISO 14801) are not provided in this summary.
- Sterilization: "A sterilization according ISO 17665-1 was carried out to confirm the recommended sterilization."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for dental implant abutments, not an AI/ML device requiring a test set for diagnostic performance evaluation. The "testing" referred to is bench testing on the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of an AI/ML device for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set for diagnostic performance evaluation is described.
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. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the context of an AI/ML device for this submission. The "truth" for substantial equivalence rests on comparison to predicate devices and standard engineering/material testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As above, this pertains to an AI/ML device, which this is not.
Summary of available information:
- Device: KLOCKNER Dental Implant Abutments (healing caps, protective caps, temporary abutments, angled abutments, straight abutments, overdenture abutments).
- Intended Use: To be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges, or overdentures.
- Study Type: 510(k) premarket notification for substantial equivalence. The "study" involves comparison to predicate devices and bench testing.
- Acceptance Criteria & Performance:
- Demonstration of substantial equivalence to predicate devices (K080224, K082200, K010132, K062129, K071585, K033243, K071357, K050705, K992334, K060291, K072624, K092248, K101798, K083876, K102804, K072055). This involves comparing indications for use, basic design, operating principles, material, and packaging.
- Bench testing for torsion and fatigue (according to ISO 14801) under worst-case conditions.
- Bioburden and sterility testing (in accordance with ISO 11737-1 and ISO 17665-1).
- The document explicitly states: "No clinical data are presented in this submission."
- Data Provenance: The document does not discuss clinical data or patient data. The "data" are from non-clinical bench tests and comparisons to specifications of predicate devices.
- Conclusion: The submitter believes the device is substantially equivalent to predicate devices, and bench testing confirms acceptable performance for its intended use. The FDA concurred with this determination.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the alphanumeric string "K122988" in a handwritten style. Below this string is a logo that reads "ASOAD" in a stylized, outlined font. Within the letter "O" of the logo, there is a graphic of a globe. Underneath the globe, the text "by KLOCKNER" is present in a smaller font size.
510(k) SUMMARY
| Date of submission: | 2013-04-15 | JUL 1 9 2013 |
|---|---|---|
| Submitter name: | SOADCO, S.L. | |
| Submitter address: | Avgda. Fiter i Rossell, 4bis - Local 2ESCALDES - ENGORDANYAD-700 (ANDORRA) | |
| Contact person: | Maria Mitjaneta | |
| Phone: | +376 800 590 | |
| Fax: | +376 800 594 | |
| e-mail: | calidad@soadco.com | |
| Device Trade Name: | Klockner Dental Implant Abutments | |
| Common Name: | Endosseous Dental Implant Abutments | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Product code: | NHA |
Legally Marketed (Predicate) Device(s):
ﺮ
510(k) Submission – Klockner Abutments
Section 5 – 510(k) Summary
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K080224 | Klockner Essential Dental Implant System, models: EC, ES, ECK | SOADCO |
| K082200 | Klockner Essential Dental Implant System, model: EC 1.5 | SOADCO |
| K010132 | Klockner Dental Implants, models SK2, NK2, S4 | SOADCO |
| K062129 | P.004 implants including abutments and healing caps | Straumann |
| K071585 | NC Healing Abutments and NC Closure Screws | Straumann |
| K033243 | ITI synOcta (Esthetic) Meso Abutments | Straumann |
| K071357 | P.004 NC Anatomic Abutments | Straumann |
| K050705 | TiUnite implants | Nobel Biocare |
| K992334 | TiN Coated Implants and Abutments | 3i |
| K060291 | PreFormance Temporary Cylinders | 3i |
| K072624 | Abutment for Provisional Restorations | Astra Tech |
| K092248 | SPI® Customizable gingiva former | Thommen Medical AG |
| K101798 | SPI® Variomulti Angled abutment | Thommen Medical AG |
| K083876 | SFI-Bar® | Cendres & Métaux |
| K102804 | SPI® Titanium Base for CADICAM | Thommen Medical AG |
| K072055 | Lava™ Frame, Lava™ Frame Shade | 3M ESPE AG |
{1}------------------------------------------------
510(k) Submission - Klockner Abutments Section 5 - 510(k) Summary
Image /page/1/Picture/1 description: The image shows the number K122988 at the top. Below the number is the word ASOD in a stylized font. The letters are bold and have a textured appearance. The letter D has a small circle inside of it.
Device Description:
Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in:
- Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system.
- Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system.
- Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system.
- Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system.
- Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System.
- Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system.
Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.
Intended Use:
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, protective caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential ES, Essential ES, Essential ECK, Essential EC 1.5, SK2 and NK2.
{2}------------------------------------------------
510(k) Submission – Klockner Abutmen Section 5 — 510(k) Summa
Image /page/2/Picture/1 description: The image shows a vertically oriented text graphic. The text appears to read "ROADHOG". The letters are bold and outlined in black, with a white fill. The image quality is somewhat degraded, giving the text a slightly pixelated appearance.
Summary of Comparison with Predicate Device
In the establishment of substantial equivalence, KLOCKNER dental implant abutnents are compared with other similar abulments alread
available on the market as indicated above
{3}------------------------------------------------
| PREDICATED DEVICE | Basic Design | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Material | Restoration | Healing/protective caps: | ||||||||||
| abutment) | Titanium ASTM F136(straight pillarabutment, screws) | Overdentureabutments: | Titanium ASTM F136 | TiN coating | POM C (cap) | Single or multiunit | Beveled design. | Angled/straight abutments: | Octagonal angled abutment design (17° and 22°), butwithout the occlusal thread. Also anodized abutments (blueand green) | |||
| Healing/protective caps: | Titanium (K062129,K071585, K071357:healing caps andprotective caps) | Similar pillar abutment design. | ||||||||||
| PredicateDevice | Indications for Use / Intended Use | Standard platform. | ||||||||||
| K080224 | The Klockner Essential implant system is especially designed forsurgical insertion into the bone using additional material toreplace the root of the teeth, acting as the support for the dentalimplants formed by implant accessories. | Titanium ASTM F136(K080224) | Overdenture abutments: | |||||||||
| KlocknerEssentialDentalImplantSystem,models: EC,ES, ECK | The Essential Solid implants are fitted with an internal octagonalconical connection combined with an external octagonalconnection measuring 1.2 mm in height. | POM C (K080224) | Ball attachment design. | |||||||||
| The Essential Cone implants are fitted with an internal octagonalconical connection. | Temporaryabutments: | Abutment implant connection: screw fixation. | ||||||||||
| The Essential ECK implants are fitted with a larger internaloctagonal conical connection than that of the Essential Coneimplants. | Titanium ASTM F136(K072624, K092248,K060291, ImplantSystem 3i DIEMTM) | Connecting principle overdenture: retentive system. | ||||||||||
| Immediate loading is appropriate for the Essential Solid,Essential Cone and Essential ECK implants when good primarystability is achieved with appropriate occlusal loading. | TiN treatment. | |||||||||||
| Abutments can be used in single tooth replacements andprinciple overdenture: retentive system. TiN treatment. |
4000 Co
510(k) Submission – Klockner Abutments
{4}------------------------------------------------
| K010132ClocknerDentalImplants,models SK2,NK2, S4 | multiple tooth restorations.8mm Implants are not indicated for use as unitary implants and for immediate load.The dental implant consist of a small conical fixture (the root-form configuration), perhaps six to eighteen millimetres in length, placed into a tiny receptacle channel which has been drilled into the bone under the gingiva (gum) at the desired location.The gingiva is elevated fi-on the underlying bone, the channel is cut, the fixture is placed, and the gingiva is sutured.In its simplest form, the implant is used to substituting the roots of teeth, to secure a denture. This is a wonderful remedy for an edentulous patient whose ridges do not allow the secure placement of a denture. In other uses the implant becomes the support for a single crown, sometimes two or more (sometime many) implants are used to support a bridge or multiple bridge. | PEEK (K060291,Implant System 3iDIEMTM)PMMA (K092248)Angled and straightabutments:Titanium ASTM F67(K080224, K033243,K062129, K101798,K102804: octagonalangled abutments,straight octacone scanabutment)Titanium (K050705:hexagonal angledabutment) | Single or multi-unit | Overdenture abutments:Ball attachment design.Abutment implant connection: screw fixation.Connecting principle overdenture: retentive system.TiN treatment. |
|---|---|---|---|---|
| K062129P.004implantsincludingabutmentsand healingcaps | The P.004 implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used.Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple | Titanium ASTM F136(K080224: straightpillar abutment,screws)Overdenturesabutments:Titanium ASTM F136(K010132, K080224,K083876)Titanium (K033243)TiN coating (K010132,K080224, K992334)POM C (K010132,K080224) | Single or multi-unit | Healing/protective caps:Conical emergence profile.Angled abutments:Angled abutment design.Standard platform. |
SOLD
510(k) Submission — Klockner Abutments
Section 5 — 510(k) Summar
5/10
{5}------------------------------------------------
510(k) Submission – Klockner Abutment Section 5 – 510(k) Summar
| tooth restorations. | .004 Healing abutments and Closure Screws are intended foruse with the Straumann P.004 Bone Level Implant system toprotect the inner configuration of the implant. Healing abutmentsgive a secondary function to maintain, stabilize and form the softtissue during the healing process. |
|---|---|
| abutments are intended to be placed into dental implants toprovide support for prosthetic reconstructions such as crowns orbridges. The ITI synOcta Meso Abutments are indicated forcemented restorations in esthetic areas of the mouth. Theabutment can be used in single-tooth replacements and multiple-tooth restorations. | |
| abutments are intended to be placed into dental implants toprovide support for prosthetic reconstructions such as crowns,bridges and overdentures.abutments can be used in single tooth replacements andmultiple tooth restorations. | |
| Nobel Biocare TiUnite Implants are root-form endosseousimplants intended to be surgically placed in the bone of theupper or lower jaw arches to provide support for prostheticdevices, such as an artificial tooth, in order to restore patientesthetics and chewing function. Nobel Biocare TiUnite Implantsare indicated for single or multiple unit restorations in splinted ornon-splinted applications. Nobel Biocare TiUnite Implants maybe placed immediately and put into immediate function providing |
Image /page/5/Picture/2 description: The image shows a vertically oriented graphic with the word "SOLD" in large, bold letters. The letters are stacked on top of each other, with "S" at the bottom and "D" at the top. The graphic appears to be a stamp or a logo, and it has a somewhat distressed or worn appearance. There is also some smaller text to the right of the word "SOLD", but it is difficult to read.
| Healing/protective caps: | ||
|---|---|---|
| N/A | Conical emergence profile | |
| Angled/straight abutments: | ||
| Single or multi-unit | Octagonal angled abutment design (15° and 20°).Titanium Base (for CAD/CAM) design.Standard platform. | |
| Overdenture abutments: | ||
| Ball attachment design.Connecting principle overdenture: retentive system. | ||
| Healing/protective caps: | ||
| Single or multi-unit | Beveled design. | |
| Angled abutments: | ||
| Single or multi-unit | Angled hexagonal design.Standard platform. |
/
{6}------------------------------------------------
| 510(k) Submission - Klockner Abutments | Section 5 - 510(k) Summary |
|---|---|
| ---------------------------------------- | ---------------------------- |
| Single or multi-unit | Single or multi-unit | Single or multi-unit | Single or multi-unit | ||
|---|---|---|---|---|---|
| Overdenture abutments:TiN treatment | Temporary abutments:Acrylic-based polymer with a titanium base. | Temporary abutments:External retentions to promote the union of acrylic material with the abutment.Conical connection to enable insertion of multiple structures. | Angled abutments:Angled abutments design (17°, 22° and 30°). | ||
| K992334TiN Coated implants and Abutments | that the initial stability requirements detailed in the surgical manuals are satisfied.TiUnite implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration and higher success rates.Endosseous implants and abutments are indicated for surgical placement into the upper and lower jaw arches as permanent support for prosthetic appliances to restore a patient's masticatory function. Proposed Titanium Nitride ("TiN") coating applied to implants / abutments improves the overall esthetics of the completed restoration. | ||||
| K0602913i PreFormance Temporary Cylinders | The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment. | ||||
| K072624Astra Tech Abutments for Provisional Restorations | Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. | ||||
| K101798Thommen SPI® VARIOmulti | Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted |
儿儿之之身影像
{7}------------------------------------------------
(k) Submission – Klockner Abutr 510(k) Sum
Image /page/7/Picture/1 description: The image shows a vertically oriented text graphic. The text appears to read "USODDA", with each letter stacked on top of the other. The letters are stylized with a blocky, somewhat distressed appearance, giving the impression of a stamp or stencil. The background is plain, which makes the text stand out.
| Section 5 - 510(k) Summary | ||||
|---|---|---|---|---|
| AngledAbutment | crowns, bridges or overdentures. | Single or multi-unit | Multi-unit | Single or multi-unit |
| K092248SPI®CustomizableGingivaFormer | The SPI® Customizable Gingiva Former is intended to be usedin conjunction with SPI® System dental implants to providetemporary support for crowns or bridges in the maxillary and/ormandibular arch. | Temporary abutments:Acrylic-based polymer with a titanium base. | Overdenture abutments:Abutment implant connection: screw fixation.Connecting principle overdenture: retentive system. | Straight abutments:Titanium Base (for CAD/CAM) design. |
| K083876SFI-Bar®abutment | The SF1-Bar® is intended to be used with the SPI ElementPlatform 4.0 mm implant (K070007) to provide support forfixation of overdentures. | Standard platform and conical connection to enableinsertion of multiple structures. | ||
| K102804SPI®TitaniumBase forCAD/CAM | Thommen Titanium Base for CAD/CAM abutments are intendedto be used in conjunction with Thommen implants and the 3MESPE Lava™ System in the maxillary and/or mandibular arch toprovide support for crowns and bridges. | Standard platform. |
n fature, technological charat of the proped devies have ben comprere with hose of the probated the probate
es following the guitant document "Class II Secial Cordel Coldener
edific references included in the proposed device share indications for use, basic design, operating principles, material and packagi with other specific predicate device
ummary Discussion of Non-Clinical Data
1737-2 and the applicable requirements taking account of their intended use. A sterlization according ISO 17665-1 was carie NER dental implant abutments have been subject to bioburden and sterility testing in accordance with ISO 11737-1
{8}------------------------------------------------
510(k) Submission — Klockner Abutmen Section 5 — 510(k) Summa
Image /page/8/Picture/1 description: The image shows the word "SOLD" in a vertical orientation. The letters are large and bold, with a distressed or textured appearance. The word is likely used to indicate that an item or property has been sold.
.
out to confirst ne recommended sterlization perior testing including tosion and fatigue testing (scording (socording (socording (so
14801) in worst-case conditions were perfo
{9}------------------------------------------------
510(k) Submission - Klockner Abutments Section 5 - 510(k) Summary
Image /page/9/Picture/1 description: The image shows the text "K122988" at the top right. Below this text is a logo that appears to read "ASOADG". The logo is stylized and has a distressed or textured appearance. The overall image is in black and white.
Summary Discussion of Clinical Data:
No clinical data are presented in this submission.
Conclusions:
We believe the intended use, the indications for use, the mode of operation and performance characteristics of the KLOCKNER Dental Implant Abutments are equivalent to the indicated predicate devices. The results of bench testing confirm acceptable device performance as per its intended use. Therefore we believe substantial equivalence of the KLOCKNER Dental Implant Abutments to the predicate devices may be established.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
July 19, 2013
Ms. Maria Mitjaneta Quality Manager Soadco, S.L. Avgda. Fiter i Rossell, 4bis -Local 2 Escaldes - Engordany Andorra AD-700
Re: K122988
Trade/Device Name: KLOCKNER Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 5, 2013 Received: July 12, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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.
{11}------------------------------------------------
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/Medica!Devices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/11/Picture/8 description: The image shows the name "Mary S. Runner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a name or title. The background is plain and does not contain any other significant elements.
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows a stylized text graphic. The text appears to read "ASDADCD" in a bold, blocky font. The letters are filled with a textured pattern, giving them a somewhat rough or distressed appearance. The overall design has a slightly tilted or angled orientation.
510(k) Submission - Klockner Abulments Section 4 - Indications for Use Statement
INDICATIONS FOR USE
K122988 510(k) Number (if known):
Device Name: KLOCKNER Dental Implant Abutments
Indications for Use:
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen 2013.07.19 09:13:57 -04'00
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anostinochoological
510(k) Number:_
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)