Who is the manufacturer of MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS?

Nobel Biocare AB filed the 510(k) submission for MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS (K093643).

What is the FDA product code for MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS?

Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477); NobelActive Multi Unit Abutments (K072570); OsseoSpeed Profile Systems (K080156); SLActive Implants (K053088); P.004 Implants (K062129).

Who can help prepare an FDA 510(k) submission like MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS

K093643 · Nobel Biocare AB · NHA · Jun 24, 2010 · Dental

Device Facts

Record ID	K093643
Device Name	MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
Applicant	Nobel Biocare AB
Product Code	NHA · Dental
Decision Date	Jun 24, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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.

Device Story

Multi-Unit Abutments are titanium/vanadium alloy prosthetic components designed to attach directly to specific endosseous dental implants (Straumann and Astra Tech platforms). They serve as an interface between the implant and the final dental restoration (crowns or bridges). Used by dental professionals in clinical settings, these abutments provide a platform for prosthetic rehabilitation. By connecting to the implant, they allow for the secure attachment of restorative components, facilitating the replacement of missing teeth. The device is available in various heights and angulations (0, 17, 30 degrees) to accommodate different anatomical requirements and restorative needs.

Clinical Evidence

Bench testing only. Fatigue testing was performed on worst-case test samples in accordance with the FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' to demonstrate safety and effectiveness.

Technological Characteristics

Materials: Titanium/vanadium alloy. Design: Endosseous dental implant abutments with internal Morse taper interfaces (hexagonal, octagonal, or slotted indices). Dimensions: Heights of 1.5, 2.5, 3.5, 4.5 mm; angulations of 0, 17, 30 degrees. Connectivity: Mechanical connection to dental implants. Sterilization: Not specified.

Indications for Use

Indicated for use as premanufactured prosthetic components connected to endosseous dental implants to aid in prosthetic rehabilitation in patients requiring dental restoration.

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

Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477)
NobelActive Multi Unit Abutments (K072570)
OsseoSpeed Profile Systems (K080156)
SLActive Implants (K053088)
P.004 Implants (K062129)

Related Devices

K101798 — SPI VARIOMULTI ANGLED ABUTMENT · Thommen Medical AG · Aug 19, 2010
K061477 — MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS · Nobel Biocare AB · Aug 11, 2006
K121688 — MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM · Prismatik Dentalcraft, Inc. · Oct 12, 2012
K161416 — Multi-unit Abutment Plus · Nobel Biocare AB · Mar 16, 2017
K203252 — Multi-unit Abutments for CONELOG · BioHorizons Implant Systems, Inc. · Mar 16, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ #### 1.4 510(k) Summary of Safety and Effectiveness ## JUN 2 4 2010 | Submitted by: | Herbert Crane Director, Global Regulatory Affairs | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba 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 Proprietary or Model Name: | Multi-Unit Abutments for Straumann and AstraTech Implant Systems | | Legally Marketed Device(s): | Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (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 Abutment for Straumann and Astra Tech Implant Systems | Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477) | NobelActive Multi Unit Abutments (K072570) | OsseoSpeed Profile 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 | - Straumann Octagon RN 4.8, WN 6.5 - Straumann Bone Level NC 3.3 Bone Level RC 4.1/4.8 - Astra Tech OsseoSpeed 3.0 (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 Tech OsseoSpeed 3.0 (yellow) 3.5/4.0 (Aqua) 4.5/5.0 (Lilac) | - Straumann Octagon RN 4.8, WN 6.5 | - Straumann Bone Level NC 3.3 Bone Level RC 4.1/4.8 | | 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 | | Abutment Angulation | - 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 Abutment for Straumann and Astra Tech Implant Systems | Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477) | NobelActive Multi Unit Abutments (K072570) | OsseoSpeed Profile Systems (K080156) | SLActive Implants (K053088) | P.004 Implants (K062129) | | | - Internal Morse taper with hexagonal index - Internal Morse taper with octagonal index - Internal Morse taper with slotted index | - Astra Tech Internal connection, double hex - Camlog Internal connection, three symmetrical arranged internal groves - Ankylos Internal conical connection | - Internal Morse taper with hexagonal index | - Internal Morse taper with hexagonal index | - Internal Morse taper with octagonal index | - Internal Morse taper with slotted index | | 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 | Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants: | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | * See Below | * See Below | * See Below | | CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE | PREDICATE | | | Multi-Unit Abutment for Straumann and Astra Tech Implant Systems | Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477) | NobelActive Multi Unit Abutments (K072570) | OsseoSpeed Profile Systems (K080156) | SLActive Implants (K053088) | P.004 Implants (K062129) | | | 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) | - 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 | | | | | K093643 {2}------------------------------------------------ Substantial Equivalence Comparison to Predicate Devices {3}------------------------------------------------ Substantial Equivalence Comparison to Predicate Devices K093643 {4}------------------------------------------------ | mandible or maxila. The device may be used equally well in single-stage or two-stage surgical procedure. It is indicated inplantation in extraction sites or implantation in partially healed alveolar ridge situations. When a one-stage surgical approach is applied, the OsseoSpeed Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit in the mplant may be immediately loaded when good primary stability is achieved and the functional load is appropriate OsseoSpeed 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 inneriment estorations 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 or single-tooth and or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewin unction. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediat SLActive Implants (K053088), Indications for Use oaded cases | The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla ond/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients P.004 Implants (K062129), Indications for Use | They are intended for immediate for multiple todh applications when good primary stability is achieve and with more implants must be used. | Abutments are intended to be placeddental implants to prosthetic reconstructions such as crowns or bridges. Meso abulments are dicated for cemented restorations particularly in esthetic areas of the mouth. The abutnent can be used in single tooth replacements and multiple ooth 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}------------------------------------------------ K093643 # 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