(170 days)
No
The document describes a dental ceramic material and blocks for creating dental restorations, focusing on material properties, processing methods (milling, firing, staining, glazing), and compatibility with existing dental systems. There is no mention of any software or algorithms that would suggest the use of AI or ML for design, analysis, or any other function.
Yes
The device, Straumann n!ce Glass Ceramic A14 Blocks, is intended to "restore chewing function" and is "used in conjunction with endosseous dental implant." This clearly indicates its role in replacing lost function or repairing a part of the body, which aligns with the definition of a therapeutic device.
No
The device is a restorative material (glass ceramic blocks) used to create mesostructures and crowns for dental implants. Its purpose is to restore chewing function, not to diagnose a condition.
No
The device is a physical ceramic block intended for milling into dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Straumann n!ce Glass Ceramic A14 Blocks are used to create dental restorations (hybrid abutments and hybrid abutment crowns) for restoring chewing function in conjunction with dental implants. This is a direct therapeutic and restorative application within the body.
- Device Description: The description details the material composition and how the blocks are processed by a trained professional to create custom dental prosthetics. This is consistent with a medical device used for treatment.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to test things like blood, urine, tissue, etc., to diagnose or monitor a condition.
The device is a medical device used for dental restoration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Straumann® n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a twopiece hybrid abutment for single tooth restoerations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base manufacturer | system | Reference | Block interface size |
|---|---|---|---|
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles and maxillae / dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional / dental laboratory
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)
- Product performance testing per ISO 6872, Dentistry-Ceramic materials, ISO 14801, Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, FDA guidance Root-form endosseous dental implants and endosseous dental implant abutments and ISO 7991, Glass—Determination of coefficient of mean linear thermal expansion.
- Transport and package testing per ISTA 2A and the standards referenced therein.
- Effects of steam sterilization on product performance consistent with FDA guidance Reprocessing Medical Devices in Health Care Setting: Validation Methodsand Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C.
- Steam sterilization validation per ISO 17665 series standards
- Biocompatibility assessment per the ISO 10993 series of standards.
- Chemical characterization per ISO 10993-18, Biological evaluation of medical devices—Part 18: Chemical characterization of materials.
- Evaluation of shelf life per ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Laboratory processing including Workflow validation, and Machinability of blocks
Conclusion: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2017
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K171773
Trade/Device Name: Straumann® n!ce Glass Ceramic A14 Blocks Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 2, 2017 Received: November 3, 2017
Dear Jennifer Jackson:
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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Straumann n!ce Glass-Ceramic A14 Blocks
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic Indications for Use (Describe) mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 1 of 1
3
1. 510(k) Summary
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Jackson, MS
Head of Regulatory Affairs and Quality
(978) 747-2509 |
| Prepared By: | Shokoufeh Khodabandeh
Regulatory Affairs and Compliance Manager
Institut Straumann AG
+41 61 965 1260 |
| Date Prepared: | December 1, 2017 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® n!ce Glass Ceramic A14 Blocks. |
| Predicate Device: | K132209 IPS e.max CAD Abutment Solutions ( Ivoclar
Vivadent, Inc.) |
| Reference Device(s): | K160262 n!ce Glass Ceramic Blocks ( Institut Straumann AG)
K151324, Variobase® for CEREC® (Institut Straumann AG)
K170354, Variobase® with n!ce™ Restorations (Institut
Straumann AG) |
| Device Description: | Straumann® n!ce® glass ceramic is a proprietary lithium
disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce®
glass-ceramic A14 blocks feature a pre milled interface that fits
the Straumann® Variobase® for CEREC®. The blocks are
further processed by the trained professional to make
individually designed mesostructure that are milled into the
desired shape of a hybrid abutment or hybrid abutment crown
using the Sirona inLab (Version3.65) and CEREC® software
(Version 4.2). n!ce® mesostructures can be |
4
additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)"
The n!ce glass-ceramic A14 blocks are intended to be used to Intended Use: manufacture mesostructure cemented to Ti-Bases as part of a two-piece abutment or abutment crown, which are placed onto dental implants.
Indications For Use: The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a twopiece hybrid abutment for single tooth restoerations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Materials: Lithium Disilicate reinforced Lithium Aluminosilicate Glass-Ceramic
5
Technological Characteristics:
A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.
| | Primary Predicate Device | Subject Devices
Straumann® n!ce Glass
Ceramic A14 Blocks | Equivalence
Discussion | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | IPS e.max CAD Abutment
Solutions (K132209) | | | | | | | | | | | | | | | | | | | | | | |
| Indications For
Use | IPS e.max CAD Abutment
Solutions is intended for use in
partially or fully edentulous
mandibles and maxillae in support
of single cementretained
restorations. The system
comprises three parts: IPS e.max
CAD ceramic structure, Ti base
and CAD/CAM software. The IPS
e.max CAD ceramic structure
cemented to the Ti base is
recommended for two-piece
hybrid abutments for single tooth
restorations and hybrid abutment
crowns, used in conjunction with
endosseous dental implants. | The Straumann n!ce Glass
Ceramic A14 Blocks are
intended to be ceramic
mesostructures cemented to
the Ti-base for a two-piece
hybrid abutment for single
tooth restorations or hybrid
abutment crowns, used in
conjunction with endosseous
dental implant to restore
chewing function. The
following compatibilities
apply:
Ti-Base
manufacturer system Reference Block
interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | | | | | | | | | | | | | | | | | | | | | Equivalent
The indications for the
n!ce Glass Ceramic A14
Blocks are within the
indications of the IPS
e.max CAD material.
The Compatibility to NC
and RC is covered
directly by the predicate
device.
Compatibility to WN and
RN is supported by the
reference device per
K151324, Variobase® for
CEREC® (Institut
Straumann AG) |
| Block Dimensions | A14 (12.4 x 14.5 x 18.0 mm)
A16 (17.8 x 15.8 x 18.0 mm ) | A14 (12.4 x 14.5 x 18.0 mm) | Equivalent
The n!ce material is
being offered in the A14
size which is also offered
for IPS e.max CAD.
n!ce material is not
offered in A16 block size
at this point. | | | | | | | | | | | | | | | | | | | | |
| Pre-milled TiBase
interface (screw
channel hole) | Sizes: Large (L)
Small (S) | Sizes: Large (L) | Equivalent
The n!ce material is
being offered with L
screw channel size which
is also offered for IPS
e.max CAD
n!ce material is not
offered with (s) screw
channel at this point | | | | | | | | | | | | | | | | | | | | |
Table 1 – Summary of the subject device and primary predicate device characteristic
6
| Feature | Primary Predicate Device
IPS e.max CAD Abutment
Solutions (K132209) | Subject Devices
Straumann® n!ce Glass
Ceramic A14 Blocks. | Equivalence
Discussion |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemical
Composition | lithium disilicate glass Ceramic | lithium disilicate – lithium
aluminosilicate reinforced
glass ceramic | Equivalent
Both materials are in the
family of lithium
disilicate glasses |
| Crystallization
State as
Supplied | Partially crystallized; final
crystallization done by dental
laboratory | Fully Crystalized | Equivalent
Both materials are fully
crystallized when fitted
in the patient's mouth |
| Mandrel Design | The mandrel is designed to be
compatible with the material
holders present on mills marketed
by Sirona under the trade names
CEREC and inLab and other third-
party mills. | The mandrel is designed to be
compatible with the material
holders present on mills
marketed by Sirona under the
trade names CEREC and
inLab and other third-party
mills. | Equivalent
Both the subject and
predicate designs can be
effectively processed in
mills designed to mate to
the Sirona style mandrel. |
| Minimum Wall
Thickness | 1.0 mm | 1.0 mm | Identical |
| Maximum
Mesostructure
Angulation | 20° | 20° | Identical |
| Design Workflow | Per the Sirona CEREC InLab, software version 3.6 and Cerec
SW (Version 4.2) | | Identical
Please note n!ce is NOT
a new material added to
software. We claim
compatibility with the
existing software cleared
for IPS e.max CAD |
| Manufacturing
Workflow | Per the Sirona CEREC MC X and MC XL milling systems | | Identical |
| Feature | Primary Predicate Device
IPS e.max CAD Abutment
Solutions (K132209) | Subject Devices | Equivalence
Discussion |
| Compatible ti-
bases | NBRS 3.5
NBRS 4.3
NBRS 5.0
NBRS 6.0
NB A 4.5
NB A 5.0 S
BL 3.3 S
BL 4.1
B C 3.4
B C 4.1
B C 5.0 | RC Variobase® for CEREC
NC Variobase® for CEREC
RN Variobase® for CEREC
WN Variobase® for CEREC | Equivalent
Compatibility of
predicate device to
Straumann Variobase®
for CEREC is supported
by the reference device
per K151324,
Variobase® for CEREC®
(Institut Straumann AG) |
| Compatible ti-
base platform
diameters | Not disclosed | NC:
4.5 mm
RC:
4.6 mm
RN:
5.0 mm
WN:
7.0 mm | Equivalent
Compatibility of predicate
device to
Straumann Variobase®
for CEREC is supported
by the reference device
per K151324,
Variobase® for
CEREC® (Institut
Straumann AG) |
7
8
| Feature | Refernce Device Device
Variobase for CEREC
(K151324) | Subject Devices
Straumann® n!ce Glass
Ceramic A14 Blocks | Equivalence
Discussion | | | | | | | | | | | | | | | | | | | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Sirona
CEREC Software (Version 4.2)
and manufactured using a Sirona
CEREC or inLab MC X or MC XL
milling unit. | The Straumann n!ce Glass
Ceramic A14 Blocks are
intended to be ceramic
mesostructures cemented to
the Ti-base for a two-piece
hybrid abutment for single
tooth restorations or hybrid
abutment crowns, used in
conjunction with endosseous
dental implant to restore
chewing function. The
following compatibilities
apply:
Ti-Base manufacturer system Reference Block interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | | | | | | | | | | | | | | | | | | | | | Equivalent
Straumann n!ce glass
ceramic was shown to be
substantially equivalent
to IPS e.max CAD per
K170354 cleared on
June 7, 2017. |
| Ti-base Material | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | | Identical
Same Ti-base is used for
subject device | | | | | | | | | | | | | | | | | | | | |
| Ti-base Diameter
(base) | NC: 4.5 mm
RC: 4.6 mm
RN: 5.0 mm
WN: 7.0 mm | | Identical
Same Ti-base is used for
subject device | | | | | | | | | | | | | | | | | | | | |
| Ti-base post
height | 4.7 mm | | Identical
Same Ti-base is used for
subject device | | | | | | | | | | | | | | | | | | | | |
| Ti-base gingiva
height | NC: 0.65 mm
RC: 0.85 mm
RN and WN: N/A - defined by the neck of the tissue level implant | | Identical
Same Ti-base is used for
subject device | | | | | | | | | | | | | | | | | | | | |
Table 2 – Substantial Equivalence Comparison with reference device Variobase for CEREC (K151324)
9
| Feature | Refernce Device
Variobase for CEREC
(K151324) | Subject Devices
Straumann® n!ce Glass
Ceramic A14 Blocks | Equivalence
Discussion |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | Straumann n!ce Glass Ceramic | Equivalent
Straumann n!ce glass
ceramic was shown to be
substantially equivalent
to IPS e.max CAD per
K170354 cleared on
June 7, 2017.
The compatibility of the
n!ce glass blocks with
the existing IPS e.max
CAD milling program is
validated as part of this
submission |
| Angulation | 20° | 20° | Identical |
| Compatible
CAD software | Sirona inLab software (Version 3.65) or Sirona CEREC Software
(Version 4.2) | | Identical |
| Compatible
milling unit | Sirona CEREC or inLab MC X or MC XL milling unit. | | Identical |
10
| Performance Data: | Test data to support the evaluation of the subject n!ce® | |
|---|---|---|
| Glass- Ceramic A14 Blocks has been submitted or | ||
| referenced as follows: |
- Product performance testing per ISO 6872, Dentistry-Ceramic materials, ISO 14801, Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, FDA guidance Root-form endosseous dental implants and endosseous dental implant abutments and ISO 7991, Glass—Determination of coefficient of mean linear thermal expansion.
- Transport and package testing per ISTA 2A and ● the standards referenced therein.
- Effects of steam sterilization on product performance consistent with FDA guidance Reprocessing Medical Devices in Health Care Setting: Validation Methodsand Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C.
- Steam sterilization validation per ISO 17665 series ● standards
- Biocompatibility assessment per the ISO 10993 series of standards.
- Chemical characterization per ISO 10993-18, Biological . evaluation of medical devices—Part 18: Chemical characterization of materials.
- Evaluation of shelf life per ASTM F1980, Standard Guide . for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- . Laboratory processing including Workflow validation, and Machinability of blocks