(277 days)
No
The description focuses on CAD/CAM processes for designing and manufacturing dental prosthetics, which are traditional digital design and manufacturing techniques, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
The device is a prosthetic component (abutment and coping) for dental implants, providing support for prosthetic reconstruction like crowns and bridges, rather than directly treating a disease or condition.
No
The device description indicates that the Straumann® CARES® Variobase™ Abutment and Coping are intended for prosthetic reconstruction and temporary dental restoration, not for diagnosing any condition.
No
The device description clearly outlines physical components (Variobase Abutments, Copings) made from materials like titanium-aluminum-niobium alloy and ceramics/acrylics, and mentions manufacturing processes involving scanning, CAD software, and milling centers to produce these physical parts. While software is used in the design process, the device itself is a physical dental abutment and coping system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental abutment and coping intended to be placed onto dental implants to support prosthetic reconstructions (crowns and bridges). This is a structural and mechanical function within the oral cavity.
- Device Description: The description details the materials and manufacturing process of the abutment and coping, which are physical components for dental restoration.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to detect diseases, conditions, or infections. This device is a physical component used for dental restoration within the body.
N/A
Intended Use / Indications for Use
The Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns dental limpiants to provide coppes® Variobase™ Abutments are indicated for and bridges. Othernally or cement-retained single tooth and bridge restorations.
The Straumann® CARES® Variobase™ Coping polycon® ae in combination with the Straumann® Variobase™ Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
Product codes
NHA
Device Description
The Straumann® CARES® Variobase™ portfolio consists of different parts which are used to provide prosthetic rehabilitation of a dental implant.
Premanufactured Variobase™ Abutments are available for the different platforms of the Straumann® dental implant system. These serve as a bonding base to which a patientspecific coping can be cemented. The coping can be made from ceramics to result in a permanent restoration, or made from acrylics to result in a temporary restoration (up to 180 davs).
The coping can be fully anatomical, i.e. it is a replica of a tooth with incisal edge or occlusal surface. It may also be of a reduced tooth shape in which case a separate crown needs to be cemented onto the coping or direct veneering needs to be applied.
Straumann® Variobase™ Abutments
The premanufactured (stock) abutments of the Straumann® CARES® Variobase™ portfolio are sometimes also referred to as "bonding bases". Straumann® Variobase™ Abutments are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®). RN (Reqular Neck), WN (Wide Neck), NC (Narrow CrossFit®) and RC (Regular CrossFit®).
Straumann® CARES® Variobase™ Copings
Straumann® CARES® Variobase™ Copings for Straumann® Variobase™ Abutments are patient-specific. CADCAM manufactured copings to be cemented to the Straumann Variobase™ Abutments.
The copings are available in ceramic (zerion™) or in acrylic (polycon® ae) material. While the ceramic copings are intended to stay in the patient's mouth as a permanent restoration, the acrylic copings are intended for temporary restoration, i.e. use should be limited to 180 days.
Both materials, ceramic or acrylic, are available in different tooth colored shades. By CAD (Computer Aided Design) and CAM (Computer Aided Manufacturing), the copings are produced so that they exactly connect to the corresponding bases. The connection between the coping and the abutment is achieved by cementation. Straumann® CARES® Variobase™ Copings are CADCAM manufactured from 510(k) cleared milling blanks.
The Straumann® CARES® Variobase™ Copings for CAMLOG® and NobelReplace™ abutments are patient-specific and can be used to restore abutments manufactured by CAMLOG® and Nobel Biocare®. It is available in ceramic and acrylic material. A customer would need to carry out a 3D scan of a CAMLOG® or NobelReplace™ abutment. Based on the scan data the customer designs a coping that fits to the CAMLOG® or NobelReplace™ abutment. After CAM manufacturing the customer will receive the coping which he needs to cement to the abutment.
In such a case. Straumann only delivers the coping. The customer needs to get the abutment and screw from the original manufacturer (CAMLOG® or Nobel Biocare®).
Straumann® CARES® Variobase™ Abutments
Straumann® CARES® Variobase™ Abutments zerion™ are a combination of the above mentioned components. Thus, a Straumann® CARES® Variobase™ Abutment consists of a Straumann® Variobase™ Abutment, the corresponding basal screw and a patientspecific Straumann® CARES® Variobase™ Coping zerion™.
Straumann® CARES® Variobase™ Temporary Abutments polycon® ae is comparable to the Straumann® CARES® Variobase™ Abutments zerion™, however, the coping in this case is made from acrylic.
The Straumann® CARES® Variobase™ Temporary Abutments polycon® ae is intended for temporary use (up to 180 days).
Straumann® CARES® Variobase™ Abutments are to be screw-fixed into a dental implant in the patient's mouth. The torque pressures of the screw are fully contained within the titanium interface.
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)
Bench testing was performed to evaluate the fatigue load limits of the proposed Straumann® Variobase™ Abutments and related product portfolio.
Dynamic fatique tests were carried out in accordance to FDA's Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
Straumann® Variobase™ Abutments cemented to different Straumann® CARES® Variobase™ Copings passed the pre-defined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093113, K101465, K083550, K113283, K052272, K082764, K081005, K072151
Reference Device(s)
K072055, K100152, K072569, K080195, K071548
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the Straumann logo. The logo consists of a stylized symbol on the left and the word "straumann" in bold, black letters on the right. The symbol appears to be two parallel lines that are cut by a third line.
5 Error! Reference source not found.
510(k) Summary of Safety and Effectiveness 5
DEC 2 1 2012
Applicant's Name and Address 5.1
Institut Straumann AG Peter Merian-Weg 12 CH-4052 Basel Switzerland
Telephone Number: +41 61 965 1482 +41 61 965 1102 Fax Number: . Andreas Petermann, Director, Corporate Regulatory Affairs Contact Person: .
5.2 Date of Submission
March 16, 2012
5.3 Name of the Device
| Trade Name: | Straumann® CARES® Variobase™ Abutments
Straumann® CARES® Variobase™ Temporary abutments
Straumann® CARES® Variobase™ Copings
Straumann® Variobase™ Abutments |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bonding Base
Patient-specific abutment coping |
| Classification Name:
Regulation Number: | Endosseous dental implant abutment
21CFR872.3630 |
5.4 Predicate Devices
| ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT | K093113 |
|---|---|
| STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR | K101465 |
| STRAUMANN DENTAL IMPLANT SYSTEM | K083550 |
| NNC CEMENTABLE ABUTMENT STRAIGHT, 15 DEGREE ANGLE, TYPE A, 15 DEGREE ANGLE, TYPE B, NNC BASAL SCREW CEMENTABLE ABUTMENTS | K113283 |
| STRAUMANN COMPUTER AIDED RESTORATION SERVICE | K052272 |
| STRAUMANN WN CARES TITANIUM ABUTMENT | K082764 |
| P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | K081005 |
1
Image /page/1/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized "S" symbol on the left and the word "straumann" in bold, black letters on the right. The "S" symbol is made up of three parallel lines that are angled slightly upwards.
5 Error! Reference source not found.
| P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS | K072151 |
|---|---|
| LAVA FRAME, LAVA FRAME SHADE | K072055 |
| SIRONA CAD/CAM SYSTEM | K100152 |
| METOXIT CAM-BLANKS | K072569 |
| NACERA Z AND NACERA Z MEDIUM | K080195 |
| WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | K071548 |
5.5 Description of the Device
Straumann® CARES® Variobase™ portfolio 5.5.1
The Straumann® CARES® Variobase™ portfolio consists of different parts which are used to provide prosthetic rehabilitation of a dental implant.
Premanufactured Variobase™ Abutments are available for the different platforms of the Straumann® dental implant system. These serve as a bonding base to which a patientspecific coping can be cemented. The coping can be made from ceramics to result in a permanent restoration, or made from acrylics to result in a temporary restoration (up to 180 davs).
The coping can be fully anatomical, i.e. it is a replica of a tooth with incisal edge or occlusal surface. It may also be of a reduced tooth shape in which case a separate crown needs to be cemented onto the coping or direct veneering needs to be applied.
5.5.2 Straumann® Variobase™ Abutments
The premanufactured (stock) abutments of the Straumann® CARES® Variobase™ portfolio are sometimes also referred to as "bonding bases". Straumann® Variobase™ Abutments are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®). RN (Reqular Neck), WN (Wide Neck), NC (Narrow CrossFit®) and RC (Regular CrossFit®).
Straumann® CARES® Variobase™ Copings 5.5.3
Straumann® CARES® Variobase™ Copings for Straumann® Variobase™ Abutments are patient-specific. CADCAM manufactured copings to be cemented to the Straumann Variobase™ Abutments.
The copings are available in ceramic (zerion™) or in acrylic (polycon® ae) material. While the ceramic copings are intended to stay in the patient's mouth as a permanent restoration, the acrylic copings are intended for temporary restoration, i.e. use should be limited to 180 days.
Both materials, ceramic or acrylic, are available in different tooth colored shades. By CAD (Computer Aided Design) and CAM (Computer Aided Manufacturing), the copings are produced so that they exactly connect to the corresponding bases. The connection between the coping and the abutment is achieved by cementation. Straumann® CARES® Variobase™ Copings are CADCAM manufactured from 510(k) cleared milling blanks.
2
Image /page/2/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized "S" symbol on the left and the word "straumann" in bold, sans-serif font on the right. The "S" symbol is made up of two parallel lines that curve and intersect.
Error! Reference source not found.
5
Ceramic (zerion™): K072569, K080195
Acrylic (polycon® ae): K071548
The Straumann® CARES® Variobase™ Copings for CAMLOG® and NobelReplace™ abutments are patient-specific and can be used to restore abutments manufactured by CAMLOG® and Nobel Biocare®. It is available in ceramic and acrylic material. A customer would need to carry out a 3D scan of a CAMLOG® or NobelReplace™ abutment. Based on the scan data the customer designs a coping that fits to the CAMLOG® or NobelReplace™ abutment. After CAM manufacturing the customer will receive the coping which he needs to cement to the abutment.
In such a case. Straumann only delivers the coping. The customer needs to get the abutment and screw from the original manufacturer (CAMLOG® or Nobel Biocare®).
510(k)s K072055 and K100152 describe similar design solutions, i.e. a patient-specific coping is designed to fit to a bonding base by a CAD system.
5.5.4 Straumann® CARES® Variobase™ Abutments
Straumann® CARES® Variobase™ Abutments zerion™ are a combination of the above mentioned components. Thus, a Straumann® CARES® Variobase™ Abutment consists of a Straumann® Variobase™ Abutment, the corresponding basal screw and a patientspecific Straumann® CARES® Variobase™ Coping zerion™.
Straumann® CARES® Variobase™ Temporary Abutments polycon® ae is comparable to the Straumann® CARES® Variobase™ Abutments zerion™, however, the coping in this case is made from acrylic.
The Straumann® CARES® Variobase™ Temporary Abutments polycon® ae is intended for temporary use (up to 180 days).
Straumann® CARES® Variobase™ Abutments are to be screw-fixed into a dental implant in the patient's mouth. The torque pressures of the screw are fully contained within the titanium interface.
5.6 Intended Use of the Device
Straumann® Variobase™ Abutments and Straumann® CARES® Variobase™ Abutments are prosthetic components that are directly connected to the endosseous dental implant intended for use as an aid in prosthetic rehabilitations.
The Straumann® CARES® Variobase™ Coping is patient-specific and can be used to restore abutments by Straumann®, CAMLOG® and NobelReplace™ abutments by Nobel Biocare®. It is available in zerion™ and polycon® ae.
The coping can be fully anatomical, i.e. it is a replica of a tooth with incisal edge or occlusal surface. It may also be of a reduced tooth shape in which case a separate crown needs to be cemented onto the coping or direct veneering needs to be applied.
Technological Characteristics 5.7
Straumann® Variobase™ Abutments are bonding bases made from a titanium-aluminumniobium alloy. They are standard medical devices (stock produced).
3
Image /page/3/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized symbol on the left and the word "straumann" in bold, sans-serif font on the right. The symbol is made up of two parallel lines that are angled and slightly offset from each other.
5 Error! Reference source not found.
Straumann® CARES® Variobase™ Copings is patient-specific medical devices, i.e. they are designed for an individual patient.
Straumann® CARES® Variobase™ Copings are designed either by a wax-up or a "CADup" procedure. Either way is processed through Straumann's CAD system consisting of the table top 3D-scanner Straumann® CARES® Scan CS2 and the corresponding CAD software Straumann® CARES® Visual. (CAD: Computer Aided Design)
In a wax-up procedure a wax model of a coping is created and scanned to be able to CAM produce the coping from a selected material. (CAM: Computer Aided Manufacturing)
In a "CAD-up" procedure, scanned data is used as the source to digitally design a coping. The design data is then sent to a Straumann milling center. The Straumann® CARES® Variobase™ Copings are CAM produced at the Straumann milling center according to the design file received and from the selected material.
Validation of the Straumann® CARES® Visual CAD software provides evidence that design parameters for the Straumann® CARES® Variobase™ Copings have met their pre-determined acceptance criteria and that dental restorations meeting their design specifications can be manufactured by Straumann CAM milling devices.
The software Straumann® CARES® Visual has been subject of 510(k) review and clearance in 510(k)s K093113 and K101465.
5.8 Performance Testing
The material used in the manufacture of Straumann® Variobase™ Abutments is a titanium-aluminum-niobium alloy which meets the requirements of ISO 5832-11.
Bench testing was performed to evaluate the fatigue load limits of the proposed Straumann® Variobase™ Abutments and related product portfolio.
Dynamic fatique tests were carried out in accordance to FDA's Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
Straumann® Variobase™ Abutments cemented to different Straumann® CARES® Variobase™ Copings passed the pre-defined acceptance criteria.
Al Response: K120822
Straumann Variobase Abutments July 6, 2012
4
Image /page/4/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized graphic to the left of the word "straumann" in a bold, sans-serif font. The graphic is composed of two parallel lines that are angled upwards and to the right, creating a sense of forward movement.
Error! Reference source not found.
5
Substantial Equivalence Comparison 5.9
The following table lists the proposed devices Straumann® CARES® Variobase™ Abutments and the respective predicate devices Straumann is claiming substantial equivalence to.
| Proposed Devices Straumann® CARES® Variobase™ Abutments | ||||
|---|---|---|---|---|
| NNC | ||||
| Narrow Neck | ||||
| CrossFit® | RN | |||
| Regular Neck | WN | |||
| Wide Neck | NC | |||
| Narrow CrossFit® | RC | |||
| Regular | ||||
| CrossFit® | ||||
| Patient specific coping Straumann® CARES® Variobase™ Coping ZrO₂ for permanent use | ||||
| Image: Coping ZrO2 | ||||
| Patient specific coping Straumann® CARES® Variobase™ Coping PMMA for temporary use | ||||
| (up to 180 days) | ||||
| Image: Coping PMMA | ||||
| Image: NNC Abutment | Image: RN Abutment | Image: WN Abutment | Image: NC Abutment | Image: RC Abutment |
| Image: NNC Abutment with base | Image: RN Abutment with base | Image: WN Abutment with base | Image: NC Abutment with base | Image: RC Abutment with base |
| Predicate Devices | ||||
| Straumann® | ||||
| NNC | ||||
| Cementable | ||||
| Abutment | ||||
| Straight | Straumann® | |||
| CADCAM | ||||
| Abutment RN, | ||||
| Titanium | Straumann® WN | |||
| CARES® | ||||
| Titanium | ||||
| Abutment | Straumann® NC | |||
| CARES® | ||||
| Titanium | ||||
| Abutments | Straumann® RC | |||
| CARES® | ||||
| Titanium | ||||
| Abutments | ||||
| K113283 | K052272 | |||
| K083550 | K082764 | K081005 | K072151 |
The proposed and the predicate devices share the following similarities.
| | Proposed device
Straumann® CARES® Variobase™ Abutments | Predicate device |
|------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Anatomical
site | Oral cavity | Oral cavity |
| Implant-
abutment-
interface | Straumann Narrow Neck CrossFit®
(NNC)
Straumann Regular Neck (RN) | Straumann Narrow Neck CrossFit®
(NNC)
Straumann Regular Neck (RN) |
5
Image /page/5/Picture/1 description: The image shows the word "straumann" in bold, black letters. To the left of the word is a logo consisting of three parallel lines that are slanted and stacked on top of each other. The logo is also black, but the lines are filled with a gray pattern.
| 5 | Error! Reference source not found. |
|---|---|
| --- | ------------------------------------ |
| | Straumann Wide Neck (WN)
Straumann Narrow CrossFit® (NC)
Straumann Regular CrossFit® (RC) | Straumann Wide Neck (WN)
Straumann Narrow CrossFit® (NC)
Straumann Regular CrossFit® (RC) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant-
borne | Yes | Yes |
| Material of
abutment | Titanium-aluminum-niobium | Titanium |
| Material of
screws | Titanium-aluminum-niobium | Titanium-aluminum-niobium |
| Material of
permanent
coping | ZrO2 (YTZ-P) | ZrO2 (YTZ-P) K072569, K080195 |
| Material of
temporary
coping | PMMA (polymethyl methacrylate) | PMMA (polymethyl methacrylate)
K071548 |
| Patient-
specific
design | CAD design by software Straumann®
CARES® Visual | CAD design by software Straumann®
CARES® Visual K052272, K083550,
K082764, K081005, K072151 |
| Duration of
use | Permanent (coping made from ZrO2)
up to 180 days (coping made from
PMMA) | Permanent |
| Sterility | Non sterile, to be sterilized by user | Non sterile, to be sterilized by user |
| Sterilization | Hot steam | Hot steam |
| Perform-
ance testing | Dynamic fatigue tests of minimal body
designs (Connection testing)
The test specimens passed the pre-
defined acceptance criteria. | K113283: Dynamic fatigue test of
abutment (Connection testing)
K052272, K083550, K082764,
K081005, K072151: Dynamic fatigue
tests of minimal body designs
(Connection testing) |
| 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.
Straumann® Variobase™ Abutments
are indicated for screw-retained single
tooth or cement-retained single tooth
and bridge restorations. | K113283: 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 Cementable
Abutments are indicated for cement-
retained single tooth and bridge
restorations.
K052272, K083550: Abutments are
intended to be placed into dental
implants to provide support for
prosthetic reconstructions such as
crowns or bridges. The Straumann®
CARES® Titanium Abutment is
indicated for cemented restorations.
The abutment can be used in single
tooth replacements and multiple tooth
restorations.
K082764: Abutments are placed into
the dental implants to provide support
for prosthetic restoration such as
crowns, bridges or overdentures. |
| 5 | The Straumann® WN CARES®
Titanium Abutment is indicated for
single tooth replacements and multiple
tooth restorations. The prosthetic
restoration is cement-retained.
K081005: Abutments are placed into
the dental implants to provide support
for prosthetic restoration such as
crowns, bridges and overdentures.
The P.004 NC CARES® Titanium
Abutment is indicated for cemented
restoration. The abutment can be used
in single tooth replacements and
multiple tooth restorations.
K072151: Abutments are placed into
the dental implants to provide support
for prosthetic restoration such as
crowns or bridges. The P.004 RC
CARES® Titanium Abutment is
indicated for cemented restoration. The
abutment can be used in single tooth
replacements and multiple tooth
restorations. | |
·
.
Straumann Variobase Abutments July 6, 2012
•
.
6
Image /page/6/Picture/1 description: The image shows the Straumann logo. The logo consists of two parallel lines that are cut by two other parallel lines, forming a parallelogram shape. To the right of the shape is the word "straumann" in a bold, sans-serif font.
5 Error! Reference source not found.
5.10 Conclusion
Non-clinical testing presented in this 510(k) premarket notification demonstrate that the components of the Straumann® CARES® Variobase™ portfolio met predefined
acceptance criteria and successfully passed testing. The information presented in this 510(k) demonstrated that the components of the Straumann® CARES® Variobase™ portfolio are substantially equivalent to the predicate devices.
Straumann believes that the components of the Straumann® CARES® Variobase™ portfolio are safe and effective for their intended use.
7
Image /page/7/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, with three wavy lines forming a shape that suggests movement or flow.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2012
Ms. Andreas Petermann Director, Corporate Regulatory Affairs Institut Straumann AG Peter Merian-Weg 12 Basel Switzerland CH-4052
Re: K120822
Trade/Device Name: Straumann® CARES® Variobase™ Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 14, 2012 Received: December 17, 2012
Dear Ms. Petermann:
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.
8
Page 2 - Ms. Petermann
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 (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 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.
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K120822
Device Name: Straumann® CARES® Variobase™ Abutments
Indications for Use:
The Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns dental limpiants to provide coppes® Variobase™ Abutments are indicated for and bridges. Othernally or cement-retained single tooth and bridge restorations.
The Straumann® CARES® Variobase™ Coping polycon® ae in combination with the Straumann® Variobase™ Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
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)
2012.12.19 Susan Runner DDS, MA 08:24:16 -05'00'
(Division Sign-Off) (Division Sign-On)
Division of Anestheslology, General Hospital Division Control, Dental Devices
K120822 510(k) Number;
Response Letter: K120822 Straumann Variobase
Straumann USA, LLC
November 27, 2012 Page 19 of 129