NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT

K113410 · Straumann USA · NHA · Jan 13, 2012 · Dental

Device Facts

Record IDK113410
Device NameNNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
ApplicantStraumann USA
Product CodeNHA · Dental
Decision DateJan 13, 2012
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations. Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days. Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Device Story

System of dental prosthetic components including solid abutments, temporary copings, and protective caps; designed for connection to Straumann Narrow Neck CrossFit (NNC) tissue level implants (3.3mm diameter). Solid abutments provide support for cement-retained crowns and bridges; temporary copings serve as bases for temporary restorations; protective caps maintain soft tissue contours during healing. Used in dental clinics by licensed dentists/prosthodontists. Components are placed directly onto implants. Solid abutments are permanent; temporary components are for short-term use. Clinical benefit includes restoration of dental function and aesthetics, and support for soft tissue healing.

Clinical Evidence

Bench testing only. Fatigue testing performed per FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'. Functional inspection and dimensional inspections conducted for temporary copings and protective caps. No clinical data provided.

Technological Characteristics

Materials: Titanium Grade 4 (abutments), Ti, TAN, PEEK, PMMA (temporary components). Design: Straight configuration abutments for 3.3mm diameter NNC implants. Principle: Mechanical connection to endosseous dental implants. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Solid abutments are for cement-retained single tooth and bridge restorations. Temporary copings (PEEK/PMMA) are for temporary restorations (up to 180/30 days). Protective caps are for soft tissue conditioning during healing (up to 6 months).

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K113410/51 JAN 1 3 2012 - 1. Applicant's Name and Address Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Senior Regulatory Affairs Specialist #### 2. Date of Submission: November 17, 2011 #### 3. Name of the Device | Trade Name: | Straumann Narrow Neck CrossFit (NNC) Solid<br>Abutments | |----------------------|---------------------------------------------------------| | | Straumann Narrow Neck CrossFit (NNC) | | | Temporary Copings | | | Straumann Narrow Neck CrossFit (NNC) Protective | | | Caps | | Common Name: | NNC Solid Abutments | | | NNC Temporary Copings | | | NNC Protective Caps | | Classification Name: | Endosseous Dental Implant Abutments | | Regulation Number: | §872.3630 | ### 4. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Reqular Neck (RN) Solid Abutment. K894844 Straumann Narrow Connection (NC) Temporary Copings, and Straumann Narrow Connection (NC) Protective Caps, K080286 #### 5. Description of the Device Straumann Narrow Neck CrossFit (NNC) Solid Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm, K111357. The abutments are made of Titanium Grade 4. The abutments are available in straight configurations only. Temporary abutments, copings and protective caps are indicated for temporary usage of up to 180 days (Ti, TAN, PEEK). Temporary copings made from PMMA are intended for temporary usage up to 30 days December 22, 2011 {1}------------------------------------------------ K113410/S1 #### 6. Indications for Use Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The specific indications for use for each device table are specified in the table below. | | Indications for Use | | | |------------------------------------------------|---------------------|--------|--------------| | Device type (as indicated on product<br>label) | crown | bridge | Overdentures | | Anatomic Abutment | × | × | | | Cementable Abutment | | | | | Solid abutment | | | | | synOcta® Milling Cylinder | | | | | synOcta abutment | | | | | Meso Abutment | | | | | Multi-Base Abutment | | × | × | | Coping, Ti | | | | | synOcta® 1.5 abutment | × | × | × | | Temporary Abutment | × | × | | | Post for temporary restoration | | | | | Temporary Coping | | | | Temporary abutments, copings and protective caps are indicated for temporary usage of up to 180 days (Ti, TAN, PEEK). Temporary copings made from PMMA are intended for temporary usage up to 30 days. #### 7. Technological Characteristics The proposed devices are substantially equivalent to the currently marketed devices. They share the same indications for use, fundamental operating principles, and materials. #### 8. Performance Testing Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments function as intended December 22, 2011 {2}------------------------------------------------ and that the modifications do not impact the performance of the device. Testing included: - 1. Performance Testing - i. Fatigue Testing in accordance to FDA guidance document "Class ll Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Temporary Copings and the Straumann Narrow Neck Crossfit (NNC) Protective Caps function as intended and that the modifications do not impact the performance of the device. Temporary copings are placed out of occlusion. Protective caps do not support a restoration. Testing included: - 1. Functional Inspection Test - 2. Dimensional Inspections #### 9. Conclusion The results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps function as intended and met the pre-determined acceptance criteria. The Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps are substantially equivalent to the named predicate devices and are safe and effective for their intended use. Response Letter: K113410 Straumann NNC Solid Abutments December 22, 2011 {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 eagle or bird symbol, with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002 JAN 1 3 2012 Ms. Elain Alan Straumann USA Senior Regulatory Affairs Specialist 60 Minuteman Road Andover, Massachusetts 01810 Re: K113410 Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) Solid Abutments Straumann Narrow Neck CrossFit (NNC) Temporary Copings Straumann Narrow Neck CrossFit (NNC) Protective Caps Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 22, 2011 Received: December 23, 2011 Dear Ms. Alan: 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 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. 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 either 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 Eederal Register. {4}------------------------------------------------ ## Page 2 - Ms. Alan 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 device-related adverse events) (21 CFR 803); good manufacturing (roperails of increasts 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Semprket 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K113410/S1 # Indications for Use Statement 510(k) Number (if known): Device Name: Straumann Narrow Neck CrossFit (NNC) Solid Abutments Indications for Use: Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations. X 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) Sween Sumr Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K113410 Special 510(k) Submission: NNC Solid Abutments November 17, 2011 Page 14 of 86 Straumann USA {6}------------------------------------------------ K113410/s1 # Indications for Use Statement 510(k) Number (if known): Device Name: Straumann Narrow Neck CrossFit (NNC) Temporary Copings Indications for Use: Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days. Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days Prescription Use X (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) h Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices 510(k) Number: k || 3410 Response Letter: K113410 Straumann NNC Solid Abutments December 22, 2011 Straumann, USA Page 20 of 24 {7}------------------------------------------------ K113410/S1 # Indications for Use Statement 510(k) Number (if known): Device Name: Straumann Narrow Neck CrossFit (NNC) Protective Caps Indications for Use: Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months. X 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) NL Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Special 510(k) Submission: NNC Solid Abutments November 17, 2011 Page 16 of 86 Straumann USA
Innolitics
510(k) Summary
Decision Summary
Classification Order
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