(211 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and fatigue testing of dental implant abutments, with no mention of AI or ML technologies.
Yes
The device is described as an "aid in prosthetic rehabilitation," which is a form of treatment or therapy for restoring function in the oral cavity.
No
Explanation: The device is a prosthetic component (abutment) used in prosthetic rehabilitation, not for diagnosing conditions. Its intended use is to aid in restoration, not diagnosis. The performance studies focus on fatigue testing, not diagnostic accuracy.
No
The device is described as a physical component made of titanium/vanadium alloy, intended to be directly connected to dental implants. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation," which is a clinical procedure performed on a patient. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a "premanufactured prosthetic component directly connected to endosseous dental implants." This describes a physical implantable device used in a surgical/dental procedure, not a test or reagent used for analyzing specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or test kits.
- Measuring analytes.
This device is clearly a medical device used in a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061477, K072570, K080156, K053088, K062129
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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 | | | | |
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 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
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