(116 days)
No
The summary describes a physical dental abutment and its compatibility with existing CAD/CAM software and milling systems. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an abutment for dental implants, which supports dental restorations, rather than directly diagnosing, treating, or preventing a disease or condition in a therapeutic manner.
No
This device, the Straumann® Variobase® for CEREC®, is an abutment for dental implants designed to support prosthetic restorations. Its purpose is structural, providing an interface for crowns and copings, not to diagnose medical conditions or diseases.
No
The device description clearly states that the device is a pre-manufactured (stock) abutment made from a titanium-aluminum-niobium (TAN) alloy, which is a physical hardware component. While it interfaces with software for design and milling, the device itself is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that the Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto dental implants to support prosthetic restorations. This is a dental prosthetic component used in vivo (within the body), not a device used to test in vitro (outside the body) specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
The device is a component of a dental restoration system, designed to interface with dental implants and support crowns or copings. This falls under the category of medical devices, specifically dental devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann® Variobase® for CEREC® abutments provide the interface for copings or crowns designed and milled using the Sirona CEREC system with four of the Straumann dental implant platforms: RN (Reqular Neck), WN (Wide Neck), RC (Regular CrossFit®), and NC (Narrow CrossFit®). The Straumann® Variobase® for CEREC® abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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)
The following performance testing was submitted in this 510(k) to support substantial equivalence:
- Dimensional verification using CEREC® e.max blocks, which confirmed the appropriate fit of the milled coping on the abutment
- Worst case dynamic fatigue testing demonstrating compliance with the minimum required fatigue properties of the Straumann® Variobase® for CEREC® abutments with cemented e.max CADCAM coping
- Process validation of the Straumann® Variobase® for CEREC® within the Sirona CEREC® InLab workflow
- Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ANSI/AAMI ST79
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Straumann USA LLC c/o Ms. Sheila Hemeon-Heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K151324
Trade/Device Name: Straumann® Variobase® for CEREC®, Abutment Models RN, WN, RC, NC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 12, 2015 Received: August 13, 2015
Dear Ms. Hemeon-Heyer:
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.
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151324
Device Name
Straumann® Variobase® for CEREC®, Abutment Models RN, WN, RC, NC
Indications for Use (Describe)
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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3
Section 6: 510(k) Summary
510(k) Summary
K151324
Submitter's Contact Information 6.1
| Submitter Name: | Straumann USA, LLC (on behalf of Institut Straumann AG) |
|---|---|
| Address: | 60 Minuteman Road |
| Andover, MA 01810 | |
| Phone Number: | 1-978-747-2575 |
| Fax Number: | 1-978-747-0023 |
| Contact Person: | Christopher Klaczyk |
| Date of Summary: | September 10, 2015 |
6.2 Name of the Device
6
| Trade Name: | Straumann® Variobase® for CEREC®, Abutment Models RN, WN,
RC, NC |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation & Class: | 21 CFR §872.3630, Class II |
| Product Code: | NHA |
Predicate Devices 6.3
Primary Predicate:
-
. K142890, Straumann® Variobase® Abutments, Models NNC, RN, WN, RC, NC
Reference Predicate(s): -
K100152, Sirona Dental CAD/CAM System (introduction of the Sirona SSO series . Ti-bases compatible with the Straumann Tissue Level implants and introduction of the CEREC MC X and MC XL and inLab MC X and MC XL mills)
-
K111421, Sirona Dental CAD/CAM System (introduction of the Sirona SBL series ● Ti-bases compatible with the Straumann Bone Level implants)
Device Description 6.4
The Straumann® Variobase® for CEREC® abutments provide the interface for copings or crowns designed and milled using the Sirona CEREC system with four of the Straumann dental implant platforms: RN (Reqular Neck), WN (Wide Neck), RC (Regular CrossFit®), and NC (Narrow CrossFit®). The Straumann® Variobase® for CEREC® abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona
4
Section 6: 510(k) Summary
CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above. The new components introduced in this 510(k) are shown below.
| Straumann® Variobase® for CEREC® Abutments | |||
|---|---|---|---|
| Image: RN | Image: WN | Image: RC | Image: NC |
| RN | WN | RC | NC |
| Catalog Number | Description |
|---|---|
| 022.0019 | RN Variobase® for CEREC® |
| 022.0020 | WN Variobase® for CEREC® |
| 022.0024 | RC Variobase® for CEREC® |
| 022.0025 | NC Variobase® for CEREC® |
| 022.0045 | RN/WN Basal screw for Variobase®* |
The Straumann® Variobase® for CEREC® abutments are compatible with the following previously cleared materials:
- . inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrO2) cleared to market per K062509 and K123664
- . IPS e.max CAD Abutment Solutions (Ivoclar IPS e.max CAD lithium disilicate glass-ceramic, LS2) cleared to market per K132209
- Telio CAD (Ivoclar Telio CAD polymethylmethacrylate, PMMA) cleared to . market per K093708
The Straumann® Variobase® for CEREC® abutments are compatible with copings and crowns fabricated using the following previously cleared mills:
- Sirona Dental CAD/CAM System (introduction of the Sirona SSO series Ti-. bases compatible with the Straumann Tissue Level implants and introduction of the CEREC MC X and MC XL and inLab MC X and MC XL mills) cleared to market per K100152
- Sirona Dental CAD/CAM System (introduction of the Sirona SBL series Ti-● bases compatible with the Straumann Bone Level implants) cleared to market per K111421
Straumann has verified that the functionality necessary to design and produce abutments compatible with the Straumann Variobase for CEREC abutments (as well as the Sirona SSO and SBL series Ti-bases) has been present in the Sirona CEREC Software since
5
Section 6: 510(k) Summary
version 4.2 (released May 2013) and in the Sirona inLab Software since version 3.65 (released January 2012). Copings and crowns designed using these or more recent versions of the Sirona software, within the design limits as defined within the design software, are compatible with the Straumann Variobase for CEREC abutments.
6.5 Indications For Use
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
6.6 Substantial Equivalence and Performance Testing
The Straumann® Variobase® for CEREC® are made of the same TAN alloy material and the same base design as primary predicate Straumann® Variobase® Abutments previously cleared for the Straumann® implant platforms RN, WN, RC and NC. The only difference is that the coronal portion of these abutments has been designed to interface with the milling blanks used to create copings and crowns with the Sirona CEREC® CAD/CAM system. The new design assures dimensional matching of the CEREC® restorations with the Straumann Variobase for CEREC ®abutments and provides an interlocking feature to augment the cemented adhesion of the restoration onto the abutment.
The subject Straumann Variobase for CEREC abutments are functionally equivalent to the reference predicate Sirona SSO series Ti-base abutments previously cleared to market per K100152 and the reference predicate Sirona SBL series Ti-base abutments previously cleared to market per K111421. The Sirona SSO series Ti-bases have been shown by Sirona to be compatible with Straumann Tissue Level implants and the Sirona SBL series Ti-bases have been shown by Sirona to be compatible with Straumann Bone Level implants. The coronal geometry of the subject devices is equivalent to the coronal geometry of the reference predicates, therefore copings and crowns fabricated using the Sirona software and milling systems will be compatible with the subject devices.
The following performance testing was submitted in this 510(k) to support substantial equivalence:
- Dimensional verification using CEREC® e.max blocks, which confirmed the . appropriate fit of the milled coping on the abutment
- . Worst case dynamic fatigue testing demonstrating compliance with the
- minimum required fatigue properties of the Straumann® Variobase® for CEREC® .
- abutments with cemented e.max CADCAM coping ●
- Process validation of the Straumann® Variobase® for CEREC® within the Sirona . CEREC® InLab workflow
6
Section 6: 510(k) Summary
- Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ● ANSI/AAMI ST79
There have been no changes to the materials, packaging, or recommended sterilization method/parameters for these devices as compared to the primary predicate devices.
7
Straumann® Variobase® for CEREC® Traditional 510(k)
Section 6: 510(k) Summary
| FEATURE | SUBJECT DEVICE
Straumann Variobase for
CEREC Abutments | PRIMARY PREDICATE
Straumann Variobase
Abutments (K142890) | EQUIVALENCE
DISCUSSION |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended to be placed into
Straumann dental implants to
provide support for prosthetic
reconstructions such as
crowns. | Prosthetic components directly
connected to the endosseous
dental implant are intended for
use as an aid in prosthetic
rehabilitations. | Substantially equivalent |
| Indications for
Use | The Straumann® Variobase® for
CEREC® are titanium alloy
abutments placed onto
Straumann dental implants to
provide support for customized
prosthetic restorations.
Straumann® Variobase® for
CEREC® abutments are
indicated for screw-retained
single tooth or cement-retained
single tooth and bridge
restorations.
All digitally designed copings
and/or crowns for use with the
Straumann® Variobase® for
CEREC® abutments are to be
designed using Sirona inLab
software (Version 3.65 or higher)
or Sirona CEREC Software
(Version 4.2 or higher) and
manufactured using a Sirona
CEREC or inLab MC X or MC XL
milling unit. | The Straumann® Variobase™
Abutment is a titanium base
placed onto Straumann dental
implants to provide support for
customized prosthetic
restorations. Straumann®
Variobase™ Abutments are
indicated for screw-retained
single tooth or cement- retained
single tooth and bridge
restorations.
All digitally designed copings
and/or crowns for use with the
Straumann® Variobase™
Abutment system are intended to
be sent to Straumann for
manufacture at a validated
milling center. | Different workflows used to
design and fabricate the
restorations. Coronal aspect of
proposed device is designed to
interface with copings/crowns
fabricated from milling blanks
containing pre- machined holes
for use with the CEREC
CADCAM system. Substantial
equivalence based on design
validation testing. |
| FEATURE | SUBJECT DEVICE
Straumann Variobase for
CEREC Abutments | PRIMARY PREDICATE
Straumann Variobase
Abutments (K142890) | EQUIVALENCE
DISCUSSION |
| Contraindications | Patients with known allergies or
hypersensitivity to chemical
ingredients of the following
materials used: titanium (Ti),
titanium alloy Ti6Al7Nb
(titanium-aluminum-niobium or
TAN) | Allergies or hypersensitivity to
materials used: Titanium alloy
Ti-6Al-7Nb (titanium- aluminum-
niobium or TAN). | Same |
| Ti-base
Material | Titanium-Aluminum-Niobium
alloy (Ti-6Al-7Nb) | Titanium-Aluminum-Niobium
alloy (Ti-6Al-7Nb) | Same |
| Abutment
Diameter (base) | 4.5 mm - 7.0 mm | 3.8 mm - 7.0 mm | Substantially equivalent
Proposed device models do
not include NNC (3.8 mm dia) |
| Abutment Height | 4.7 mm | 3.5 – 4.5 mm | Substantially equivalent |
| Coping/ Crown
Material | Compatible with any milling
blanks cleared for use with the
CEREC MC X and MC XL
milling systems (i.e., containing
the pre-machined mounting
hole). Currently available:
inCoris ZI meso (K123664)
Ivoclar IPS e.max CAD
(K132209)
Ivoclar Telio CAD (K093708) | TraditionalWorkflow:
Type 4 Metals (ISO 22674) IPS
e.max® Press Ceramic Digital
Workflow:
polycon® ae (temporary)
zerion® (permanent)
IPS e.max® CAD Ceramic
(permanent)
coron® (permanent) | Substantially equivalent
All materials to be used for
coping/crown have previously
been cleared and are not the
subject of this
510(k). |
| Design Workflow | Per the Sirona CEREC InLab,
software version 3.6 or later | Wax-up or Open CAD | Substantially equivalent |
| FEATURE | SUBJECT DEVICE
Straumann Variobase for
CEREC Abutments | PRIMARY PREDICATE
Straumann Variobase
Abutments (K142890) | EQUIVALENCE
DISCUSSION |
| Manufacturing
Workflow | Per the Sirona Cerec MC X
and MC XL milling systems | Traditional casting or
pressing or Straumann
Milling | Substantially equivalent |
| Mode of Attachment | Screw-retained or cement
retained | Screw-retained or cement
retained | Same |
| Reusable | No | No | Same |
8
Straumann® Variobase® for CEREC® Traditional 510(k)
Section 6: 510(k) Summary
9
Straumann® Variobase® for CEREC® Traditional 510(k)
Section 6: 510(k) Summary
10
Section 6: 510(k) Summary
6.7 Conclusion
The documentation submitted in this premarket notification demonstrates that the Straumann® Variobase® for CEREC® abutments are substantially equivalent to the primary predicate Straumann® Variobase® Abutments and the reference predicate Sirona Ti-base devices previously cleared as being compatible with the implants of the Straumann Dental Implant System.