(211 days)
The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.
This document is a 510(k) Summary of Safety and Effectiveness for Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems. This device is an endosseous dental implant abutment. The submission demonstrates substantial equivalence to previously cleared devices.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by FDA Guidance) | Reported Device Performance |
|---|---|
| Fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing must indicate that the abutments are substantially equivalent to the identified predicates. | Worst-case test samples were subjected to fatigue testing. The testing indicates that the abutments are substantially equivalent to the identified predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set. It mentions "worst-case test samples" were identified and tested. The data provenance is within a laboratory setting, as it refers to "fatigue testing" of the physical devices. No country of origin for the data is explicitly stated beyond Nobel Biocare USA LLC's address in California. The study is prospective in the sense that the testing was performed on the new device to demonstrate its equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a physical medical device (dental implant abutment) that undergoes mechanical and material testing, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for this type of device is compliance with specific mechanical and material standards as outlined in FDA guidance documents.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is mechanical testing of a physical device against established standards, not a diagnostic or AI study requiring adjudication of interpretations.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. This submission is for a physical dental implant abutment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by physical standards and performance requirements for endosseous dental implant abutments, as outlined in the "FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This involves demonstrating mechanical properties (like fatigue strength) are equivalent to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI or machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study:
The study conducted was a fatigue testing of "worst-case test samples" of the Multi-Unit Abutments for Straumann and AstraTech Implant Systems. The objective was to demonstrate that these abutments meet the safety and effectiveness requirements by being substantially equivalent to legally marketed predicate devices (listed in the "Legally Marketed Device(s)" section of the document). The criteria for "substantial equivalence" were based on the FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, which sets out performance standards, particularly related to fatigue life. The testing results indicated that the new device met these criteria, thereby proving its substantial equivalence to the predicates.
{0}------------------------------------------------
1.4 510(k) Summary of Safety and Effectiveness
JUN 2 4 2010
| Submitted by: | Herbert CraneDirector, Global Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | March 29, 2010 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietaryor Model Name: | Multi-Unit Abutments for Straumann and AstraTech Implant Systems |
| Legally Marketed Device(s): | Multi-Unit Abutments for Astra Tech, Camlog and Ankylos ImplantSystems (K061477)NobelActive Multi Unit Abutments (K072570)OsseoSpeed Profile Systems (K080156)SLActive Implants (K053088)P.004 Implants (K062129) |
Device Description:
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.
Indications for Use:
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
The abutments fit the following implant platforms.
- Straumann Octagon Regular Neck 4.8 -
- Straumann Octagon Wide Neck 6.5 .
- Straumann Bone Level NC 3.3 -
- Straumann Bone Level RC 4.1/4.8 -
- Astra Tech OsseoSpeed 3.0 (yellow) -
- Astra Tech OsseoSpeed 3.5/4.0 (Aqua) 【
- Astra Tech OsseoSpeed 4.5/5.0 (Lilac) す
Summary of testing to demonstrate safety and effectiveness
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems were analyzed to identify worst-case test samples. These worst-case test samples were subject to fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the abutments are substantially equivalent to the identified predicates.
{1}------------------------------------------------
Substantial Equivalence Comparison to Predicate Devices
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE |
|---|---|---|---|---|---|---|
| Multi-Unit Abutmentfor Straumann andAstra Tech ImplantSystems | Multi-UnitAbutments for AstraTech, Camlog andAnkylos ImplantSystems(K061477) | NobelActive MultiUnit Abutments(K072570) | OsseoSpeedProfile Systems(K080156) | SLActive Implants(K053088) | P.004 Implants(K062129) | |
| Anatomical Site | - Oral Cavity | - Oral Cavity | - Oral Cavity | - Oral Cavity | - Oral Cavity | - Oral Cavity |
| Material | - Titanium Alloy | - Titanium- Titanium Alloy | - Titanium Alloy | - Titanium | - Titanium | - Titanium |
| Platform | - StraumannOctagon RN 4.8,WN 6.5- StraumannBone Level NC3.3 Bone LevelRC 4.1/4.8- Astra TechOsseoSpeed3.0 (yellow)3.5/4.0 (Aqua)4.5/5.0 (Lilac) | - Astra Tech 3.5,4.0, 4.5, 5.0 mm- Camlog 3.3, 3.8,4.3, 5.0, 6.0 mm- Ankylos 3.5, 4.5,5.5, 7.0 mm | - NobelActive | - Astra TechOsseoSpeed 3.0(yellow) 3.5/4.0(Aqua) 4.5/5.0(Lilac) | - StraumannOctagon RN 4.8,WN 6.5 | - StraumannBone LevelNC 3.3 BoneLevel RC4.1/4.8 |
| Abutment Height | - 1.5, 2.5, 3.5, 4.5 | - 1.5 mm | - 1.5, 2.5, 3.5, 4.5 | N/A | N/A | N/A |
| AbutmentAngulation | - 0, 17, 30 deg | - 0 deg | - 0, 17, 30 deg | - 0, 20 deg | - 0, 15 deg | - 0, 15 deg |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE |
| Interface Design | Multi-Unit Abutmentfor Straumann andAstra Tech ImplantSystems | Multi-UnitAbutments for AstraTech, Camlog andAnkylos ImplantSystems(K061477) | NobelActive MultiUnit Abutments(K072570) | OsseoSpeedProfile Systems(K080156) | SLActive Implants(K053088) | P.004 Implants(K062129) |
| - Internal Morsetaper withhexagonal index- Internal Morsetaper withoctagonal index- Internal Morsetaper with slottedindex | - Astra TechInternalconnection,double hex- Camlog Internalconnection, threesymmetricalarranged internalgroves- Ankylos Internalconicalconnection | - Internal Morsetaper withhexagonal index | - Internal Morsetaper withhexagonal index | - Internal Morsetaper withoctagonal index | - InternalMorse taperwith slottedindex | |
| Indications for Use | Nobel Biocare'sMulti-UnitAbutments forStraumann andAstraTech ImplantSystems arepremanufacturedprostheticcomponentsdirectly connectedto endosseousdental implants andare intended for useas an aid inprosthetic | Nobel Biocare'sMulti-Unit Abutmentis apremanufacturedprostheticcomponent intendedfor use as an aid inprostheticrehabilitation.Nobel Biocare'sMulti-UnitAbutments fit thefollowingendosseousimplants: | NobelActive MultiUnit Abutment is apre-manufacturedprostheticcomponent directlyconnected to theendosseous dentalimplant and isintended for use asan aid in prostheticrehabilitation. | * See Below | * See Below | * See Below |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE |
| Multi-Unit Abutmentfor Straumann andAstra Tech ImplantSystems | Multi-UnitAbutments for AstraTech, Camlog andAnkylos ImplantSystems(K061477) | NobelActive MultiUnit Abutments(K072570) | OsseoSpeedProfile Systems(K080156) | SLActive Implants(K053088) | P.004 Implants(K062129) | |
| rehabilitation.The abutments fitthe followingimplant platforms.- Straumann -Octagon RegularNeck 4.8- Straumann -Octagon WideNeck 6.5- Straumann -Bone Level NC3.3- Straumann -Bone Level RC4.1/4.8- Astra Tech -OsseoSpeed 3.0(yellow)- Astra Tech -OsseoSpeed3.5/4.0 (Aqua)- Astra Tech -OsseoSpeed4.5/5.0 (Lilac) | - Astra Tech 3.5,4.0, 4.5, 5.0 mm- Camlog 3.3, 3.8,4.3, 5.0, 6.0 mm- Ankylos 3.5, 4.5,5.5, 7.0 mm |
{2}------------------------------------------------
Substantial Equivalence Comparison to Predicate Devices
{3}------------------------------------------------
Substantial Equivalence Comparison to Predicate Devices
{4}------------------------------------------------
| mandible or maxila. The device may be used equally well in single-stage or two-stage surgical procedure. It is indicated inplantation inextraction sites or implantation in partially healed alveolar ridge situations. When a one-stage surgical approach is applied, theOsseoSpeed Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit in themplant may be immediately loaded when good primary stability is achieved and the functional load is appropriateOsseoSpeed Profile Systems (K080156), Indication for Use | The modifiel surface, hough in her far belew hat neet, provical in teet, provical neet, provices a barate substrate in the institut in the invisent only the innerimentestorations may not be appropriate in such situations. | SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function orsingle-tooth and or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewinunction. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediatSLActive Implants (K053088), Indications for Useoaded cases | The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla ond/or mandbular arches to support crowns bridgesor overdentures in edentulous or partially edentulous patientsP.004 Implants (K062129), Indications for Use | They are intended for immediate for multiple todh applications when good primary stability is achieve and withmore implants must be used. | Abutments are intended to be placeddental implants to prosthetic reconstructions such as crowns or bridges. Meso abulments aredicated for cemented restorations particularly in esthetic areas of the mouth. The abutnent can be used in single tooth replacements and multipleooth restorations. |
|---|---|---|---|---|---|
bstantial Equivalence Comparison to Predicate Device
:
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 4 2010
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K093643
Trade/Device Name: Multi-Unit Abutments for Straumann and Astra Tech Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseuos Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2010 Received: June 24, 2010
Dear Mr. Crane:
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 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 Federal Register.
{6}------------------------------------------------
Page 2- Mr. Crane
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 practice requirements as set forth in the quality systems (OS) 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 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,
Susan Penner
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
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): 《 ○93ሬ 43
Device Name: Multi-Unit Abutments for Straumann and Astra Tech Implant Systems
Indications For Use:
1.3
The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.B.BetzDDS/R. Susanna Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: KD93643
§ 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.)