(143 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a dental implant system, is intended to restore patients' esthetics and chewing function, which addresses a health-related condition. While it provides support for prosthetic devices (artificial teeth), its core function is to restore or improve physiological function (chewing) and anatomical appearance (esthetics).
No
The device is described as an endosseous implant intended to provide support for prosthetic devices to restore patients' esthetics and chewing function, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium and zirconia, including implants, abutments, and closure screws. The performance studies also focus on physical properties like sterilization, fatigue testing, and surface analysis. There is no mention of software as the primary or sole component.
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 Spiraltech Dental Implants are surgically placed in the jaw to support prosthetic devices. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details the materials and design of the implants and abutments, which are physical components intended for implantation.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used in vitro (outside the body).
- Mentioning reagents, calibrators, or controls.
The device is a medical device intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.
Solo One Piece 3.0 and 3.3 implants. Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.
SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.
Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
lateral incisor in the maxilla and/or a central or lateral incisor in the mandible
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)
Sterilization validation was conducted for the implants according to the respective standards, ISO 11737-1, ISO 11737-2, ISO 11137-1, ISO 11137-2, and ISO 11137-3 (for gamma radiation validation) and ISO 17665-1 and ISO 17665-2 (for moist heat validation). This testing included USP 85, USP 161 and LAL method testing on the implants. The shelf life for the implants supplied sterile is 5 years based on accelerated testing (ASTM F1980) with one year of real time data (ASTM F1929-12, ASTM F88/F88M).
Several designs of SpiralTech Dental Implants were fatigue tested according to ISO 14801. Justification was provided to show the design tested was the worst case for that connection type. The implants with SLA and RBM surface treatments were evaluated by SEM and EDS for surface analysis.
The temporary abutments are made of PEEK. The implants are Ti6Al4V with either SLA or RBM surface treatment. Abutments are either Ti6AL4V or ZrO2. Chemical characterization of the ZrQ2 was provided. Cytotoxicity (MEM elution) has been provided to demonstrate biocompatibility for all subject devices composed of these identified materials.
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.
Nobel Biocare K071370
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.
K133731 K020646 K102436 Biohorizons K121787 Zimmer K082639 MIS K080162 K103089 Abutments - Biohorizons K071638 Alpha Bio Tec K063364 MSI K112162
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
SpiralTech Superior Dental Implants Daniel Rosenthal Director of Sales and Marketing 875 N. Michigan Ave Suite 3106 Chicago, Illinois 60611
Re: K170372
Trade/Device Name: SpiralTech Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 29, 2017 Received: June 5, 2017
Dear Daniel Rosenthal:
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
1
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Andrew I. Steen -S
for Lori A. Wiggins, MPT, CLT 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
510(k) Number (if known) K170372
Device Name SpiralTech Dental Implant System
Indications for Use (Describe)
The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.
Solo One Piece 3.0 and 3.3 implants. Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.
| 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
510(k) Summary June 17, 2017
SpiralTech Dental Implants
Company: SpiralTech Superior Dental Implants
Address: 875 N. Michigan Ave Suite 3106 Chicago, IL 60611
Phone: 312-440-7777
Contact Person: Daniel Rosenthal
Contact email: info@spiraltech.com
Trade Name: SpiralTech Dental Implant System
Common Name: dental implant and abutment system
Classification Name: endosseous dental implant
Regulation Number: 21 CFR 872.3640
Product Code: DZE
Secondary Product Code: NHA
Predicate Device: Nobel Biocare K071370
Reference Devices: Implants – Nobel Biocare K133731 K020646 K102436 Biohorizons K121787 Zimmer K082639 MIS K080162 K103089 Abutments - Biohorizons K071638 Alpha Bio Tec K063364 MSI K112162
Indications for Use
The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.
Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.
4
Device Description
The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.
SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.
Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.
Sizes
The Hex versions of the designs are available in 3.3, 3.5, 4.3, 5.0, and 6.0 with lengths 8, 10, 11, 13, and 15. The conical versions start at a diameter of 3.5 but are otherwise available in the same sizes and lengths with one exception, the Ultimate and ESi designs also come in 3.0 diameter with lengths of 10, 11, 13, and 15.
| Diameter (mm) | Implant Lengths (mm) |
|---|---|
| 3.3mm | 8, 10, 11.5, 13, 15mm |
| 3.5mm | 8, 10, 11.5, 13, 15mm |
| 4.3mm | 8, 10, 11.5, 13, 15mm |
| 5.0mm | 8, 10, 11.5, 13, 15mm |
| 6.0mm | 8, 10, 11.5, 13, 15mm |
Hex version implant sizes:
Conical version implant sizes:
| Diameter (mm) | Implant Lengths (mm) |
|---|---|
| 3.0mm | 10, 11.5, 13, 15mm – only for Ultimate and ESi implants |
| 3.5mm | 8, 10, 11.5, 13, 15mm |
| 4.3mm | 8, 10, 11.5, 13, 15mm |
| 5.0mm | 8, 10, 11.5, 13, 15mm |
| 6.0mm | 8, 10, 11.5, 13, 15mm |
5
The Solo one piece implant comes in diameters 3.0, 3.3, 3.75, and 4.2. It has lengths of 10, 11, 13 and 15.
The smallest diameter conical versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0° and 15° titanium conical abutment models.
The smallest diameter hex versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0°, 15° and 25° titanium hex abutment models.
Non-Clinical Testing
Sterilization validation was conducted for the implants according to the respective standards, ISO 11737-1, ISO 11737-2, ISO 11137-1, ISO 11137-2, and ISO 11137-3 (for gamma radiation validation) and ISO 17665-1 and ISO 17665-2 (for moist heat validation). This testing included USP 85, USP 161 and LAL method testing on the implants. The shelf life for the implants supplied sterile is 5 years based on accelerated testing (ASTM F1980) with one year of real time data (ASTM F1929-12, ASTM F88/F88M).
Several designs of SpiralTech Dental Implants were fatigue tested according to ISO 14801. Justification was provided to show the design tested was the worst case for that connection type. The implants with SLA and RBM surface treatments were evaluated by SEM and EDS for surface analysis.
The temporary abutments are made of PEEK. The implants are Ti6Al4V with either SLA or RBM surface treatment. Abutments are either Ti6AL4V or ZrO2. Chemical characterization of the ZrQ2 was provided. Cytotoxicity (MEM elution) has been provided to demonstrate biocompatibility for all subject devices composed of these identified materials.
Substantial Equivalence
The widths and lengths of the implants are in the same range as the predicate and reference devices. The materials used for all the devices are commonly used in the predicate and reference devices. As can be seen in the table, the thread designs incorporate types of threads used in the predicate and reference devices. The implant connections types are ones used in several predicate devices as can be seen in the table. The indications for use are the predicate device, except for adding more restrictive placement for the Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants. The surface treatments available are the same types as those used on predicate devices.
The testing done for sterilization validation is the same type of testing done on the predicate and reference devices. Also the predicate and reference devices underwent the same ISO 14801 testing.
See the Substantial Equivalence Tables.
6
Conclusion
The SpiralTech Dental Implants are substantially equivalent to the predicate device based on design including implant connection, materials, surface treatments, dimensions, and testing completed.
7
Substantial Equivalence Table
Implant Table
| | SpiralTech | NobelActive
K071370 and
K133731 | NobelReplace
K020646 | NobelActive
3.0
K102436 | Internal
Tapered
Plus from
Biohorizons
K121787 | Tapered
SwissPlus
from
Zimmer
K082639 | MIS Uno
K080162 | MIS
Short
implants
K103089 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------|------------------------------------------------------------|---------------------------------------------------|--------------------|-------------------------------------|
| Material | Ti6Al4V | CP Titanium | Ti6Al4V | CP Titanium | Ti6Al4V | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Diameters | 3.0 – 6.0
with the
exact sizes
varying
among the
designs. | 3.5, 4.3, 5.0,
5.5 | 3.5, 4.3, 5.0,
6.0 | 3.0 | 3.8, 4.6, 5.8 | 3.7, 4.8 | 3.0 and
3.5 | 4.2, 5.0,
6.0 |
| Lengths | 8, 10, 11, 13,
15 with not
all lengths
available for
all sizes and
designs | 8.5, 10, 11.5 | 10, 13, 16 | 10, 11.5, 13,
15 | 7.5, 9, 10.5,
12, 15 | 8, 10, 12,
14 | 10, 13, 16 | 6.0 |
| Indications
for Use | The
Spiraltech
Dental
Implants are
endosseous
implants
intended to
be surgically
placed in the
upper or
lower jaw
arches to | Nobel
Biocare's
NobelActive
implants are
endosseous
implants
intended to
be surgically
placed in the
bone of the
upper or
lower jaw | | | | | | |
8
| provide
support for
prosthetic
devices,
such as an
artificial
tooth, in
order to
restore
patients
esthetics
and chewing
function.
Spiraltech
implants are
intended for
single or
multiple unit
restorations
on splinted
or non-
splinted
applications.
The implants
ESi Dynamic
and Ultimate
are intended
for
immediate
loading
when good
primary
stability is
achieved | arches to
provide
support for
prosthetic
devices, such
as an
artificial
tooth, in
order to
restore
patient
esthetics and
chewing
function.
Nobel
Biocare's
Nobelactive
implants are
indicated for
single or
multiple unit
restorations
in splinted
and non-
splinted
applications.
Nobel
Biocare's
NobelActive
implants are
intended for
immediate
loading when
good primary | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| and with | stability is | | | | |
| appropriate | achieved and | | | | |
| occlusive | with | | | | |
| loading. | appropriate | | | | |
| These | occlusal | | | | |
| implants | loading. | | | | |
| [along with | | | | | |
| Premium | | | | | |
| and One | | | | | |
| Piece] can | | | | | |
| also be used | | | | | |
| for loading | | | | | |
| after a | | | | | |
| conventional | | | | | |
| healing | | | | | |
| period. | | | | | |
| Solo One | | | | | |
| Piece 3.0 | | | | | |
| and 3.3 | | | | | |
| implants, | | | | | |
| Ultimate | | | | | |
| (conical) 3.0 | | | | | |
| implants, | | | | | |
| and ESi | | | | | |
| (conical) 3.0 | | | | | |
| implants are | | | | | |
| intended to | | | | | |
| replace a | | | | | |
| lateral | | | | | |
| incisor in the | | | | | |
| maxilla | | | | | |
| and/or a | | | | | |
| central or | | | | | |
| lateral | | | | | |
9
10
| | incisor in the
mandible.
Mandibular
central and
lateral
incisors
must be
splinted if
using two or
more 3.0
and/or 3.3
implants
adjacent to
one another. | | | | | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---|---|--|
| ESI thread
design
reference
device | | | | | X | |
| Dynamic
thread
design
reference
device | | | | X | | |
| Premium
thread
design
reference
device | | | X | | | |
| Ultimate
thread
design
reference
and
predicate | | X | | | | |
11
| device | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| One Piece | |||||||||
| thread | |||||||||
| design | |||||||||
| reference | |||||||||
| and | |||||||||
| predicate | |||||||||
| device | X | ||||||||
| Radiation | |||||||||
| Sterilization | |||||||||
| of the | |||||||||
| Implants | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Validated | |||||||||
| Steam | |||||||||
| Sterilization | |||||||||
| Instructions | |||||||||
| supplied | |||||||||
| for | |||||||||
| abutments | Yes | Yes | Yes | Yes | Yes | Yes | No abutments | Yes | |
| Subject of | |||||||||
| Fatigue | |||||||||
| testing | |||||||||
| meeting | |||||||||
| ISO 14801 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Connection | |||||||||
| interface | hex, conical | hex | conical | hex | hex | octagon | N/A | hex | |
| Surface | |||||||||
| Treatments | |||||||||
| Available | SLA, RBM | Acid etched | HA, acid | ||||||
| etched | TiUnite | RBM | HA, RBM | SLA | SLA |
12
Abutment Table
| Abutments | | Hex | Conical
NP | Conical RP | Slim
Conical |
|----------------------------------------------------------------|-------------------|----------------------------------|----------------------------------|----------------------------------|-----------------|
| Flat Titanium
Straight | 3.8
(Narrow) | Facial
Heights -
5,7,9,11 | Facial
Heights -
5,7,9,11 | Facial
Heights –
5,7,9,11 | |
| Flat Titanium
Straight | 4.5
(Standard) | Facial
Heights –
5,7,9,11 | Facial
Heights -
5,7,9,11 | Facial
Heights -
5,7,9,11 | |
| Flat Titanium
Straight | 5.5 (Wide) | Facial
Heights -
5,7,9,11 | | Facial
Heights -
5,7,9,11 | |
| Flat Titanium
Shoulder | 3.8 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3 | |
| Flat Titanium
Shoulder | 4.5 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3 | |
| Flat Titanium
Shoulder | 5.5 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3 | |
| Anatomic
Titanium | 4.5 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | |
| Anatomic
Titanium | 5.5 | Facial
Heights -
1,2,3 | Facial
Heights –
1,2,3 | Facial
Heights -
1,2,3 | |
| 15 Degree
Angulated - | 4.7 | Facial
Heights - | Facial
Heights – | Facial
Heights - | |
| Titanium | | | | | |
| 25 Degree
Angulated -
Titanium | 5.2 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | |
| 30 Degree
Angulated -
Titanium | 5.3 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | |
| Flat Titanium
Slim | 3.7 | | | Facial
Heights -
1,2,3 | |
| 15 degree
Angulated
Titanium slim | 3.7 | | | Facial
Heights -
1,2,3 | |
| Titanium
Multiunit
Abutments -
Straight | - | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | |
| Titanium
Multiunit
Abutments -
17 Degree
angulated | - | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | Facial
Heights -
1,2,3,4 | |
| Titanium
Multiunit
Abutments -
30 degree
angulated | - | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | Facial
Heights -
1,2,3 | |
| Titanium
Healing
Abutment | 3.8 | Facial
Heights -
2,3,4,5,6 | Facial
Heights -
2,3,4,5,6 | Facial
Heights -
2,3,4,5,6 | |
| Titanium
Healing | 4.5 | Facial
Heights - | Facial
Heights - | Facial
Heights - | |
| Abutment | | | | | |
| Titanium
Healing
Abutment | 5.5 | Facial Heights -
2,3,4,5,6 | Facial Heights -
2,3,4,5,6 | Facial Heights -
2,3,4,5,6 | |
| Zirconia
Anatomic
Abutments | 4.5 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | | |
| Zirconia
Healing
Abutment | 3.8 | Facial Heights -
2,3,4,5,6 | Facial Heights -
2,3,4,5,6 | Facial Heights -
2,3,4,5,6 | |
| Zirconia
Healing
Abutment | 5.5 | Facial Heights -
3,4 | | Facial Heights -
3,4 | |
| PEEK
Temporary Flat
Abutments | Length - 10 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| PEEK
Temporary Flat
Abutments | Length - 11 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| PEEK
Temporary Flat
Abutments | Length - 12 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| PEEK
Temporary
anatomic
Abutments | Length - 10 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| PEEK
Temporary
Anatomic
Abutments | Length - 11 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| PEEK
Temporary
Anatomic
Abutments | Length - 12 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | Facial Heights -
1,2,3 | |
| Abutments | | | | | |
| Implant
Prosthetic
Indicator | - | Facial Heights –
1,2,3,4,5,6 | Facial Heights –
1,2,3,4,5,6 | Facial Heights –
1,2,3,4,5,6 | |
| Ball
Attachments | - | Facial Heights –
1,2,3,4,5,6 | Facial Heights –
1,2,3,4,5,6 | Facial Heights –
1,2,3,4,5,6 | |
13
14
15
16
| | SpiralTech (Internal Hex
and Conical
Connection) | Biohorizon (Conical
Internal Hex) K071638 | Alpha Biotec (Internal
Hex Connection)
K063364 | MIS (Internal Hex)
K112162 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Straight Titanium
Abutments | Diameters – 3.8,4.5,5.5
Facial Heights - 5,7,9,11 | Laserlok Simple
abutments
Diameters - 3.8,4.5,5.5
Facial Heights - 5,7,9,11 | Titanium Abutments
Diameters -3.85,4.5,5.3
Facial Heights - 6,7,8,9 | Straight Titanium
Abutments
Diameters - 3.8,4.5,5.5
Facial Heights - 5,7,9,11 |
| Anatomic Titanium
abutments | Diameter - 4.5
Facial Heights - 1,2,3,4
Diameter - 5.5
Facial Heights - 1,2,3 | Straight Esthetic
connections
Diameters –
3.0,3.5,4.5,5.7
Facial Heights - 1,2,3 | Anatomic Abutments
with Emergence Profile
Diameter - 4.3
Facial Heights - 1.5,2
Diameter - 5.5
Facial Heights - 2,3 | |
| Shoulder Titanium
abutments | Diameter - 3.8
Facial Heights - 1,2,3
Diameter - 4.5
Facial Heights - 1,2,3,4
Diameter - 5.5
Facial Heights - 1,2,3 | | Straight abutments with
various cuff heights
Diameter - 3.85
Facial Heights -
0.5,1.5,2.5
Diameter - 4.8
Facial Heights - 1,2,3,4
Diameter - 5.6
Facial Heights - 2,4 | |
| Angulated titanium
abutments | 15 Degree - Diameter -
4.7 - Heights - 1,2,3
25 Degree - Diameter -
5.2 - Heights - 1,2,3
30 Degree - Diameter -
5.3 - Heights - 2,3,4,5 | 15 Degree - Diameter -
4.5,5.7 - Heights - 2,3
25 Degree - Diameter -
5.2 - Heights - 1,2,3
30 Degree - Diameter -
5.3 - Heights - 2,3,4,5 | Angled Abutments
15 Degree - Diameter -
4.5,4.8,5.1 - Heights -
1,2,3
25 Degree - Diameter -
4.7, 5.3 - Heights - 1,2,3 | |
| | | | 35 Degree - Diameter -
4.65, 5.3 - Heights -
1,2,3 | |
| Titanium Healing
abutments | Diameter - 3.8
Facial Heights -
2,3,4,5,6
Diameter - 4.5
Facial Heights -
2,3,4,5,6
Diameter - 5.5
Facial Heights -
2,3,4,5,6 | Titanium Healing
abutments
Diameter - 3.8
Facial Heights - 1,3,5
Diameter - 4.7
Facial Heights - 1,3,5
Diameter - 5.7
Facial Heights - 1,3,5 | Titanium Healing
abutments
Diameter - 3.8
Facial Heights - 3,4,5
Diameter - 4.5
Facial Heights -
2,3,4,5,6,7
Diameter - 5,
5.5,6,7,7.8
Facial Heights - 3,5 | Titanium Healing
abutments
Diameter - 3.8
Facial Heights -
2,3,4,5,6,7
Diameter - 5.5
Facial Heights - 3,4,5,6 |
| Zirconia Abutments -
Anatomic | Diameter - 4.5
Facial Heights - 1,2,3 | | | Straight Anatomic
Zirconia
Diameter - 4.5
Facial Heights - 1,2,3,4 |
| Zirconia Healing
abutments | | | | |
| Multi unit abutments | Straight
Diameter - 4.7
Facial Heights - 1,2,3,4
17 Degree
Diameter - 5.3
Facial Heights -1,2,3
30 Degree
Diameter - 5.4
Facial Heights - 1,2,3 | Multi unit abutments
Straight
Diameter - 4.5
Facial Heights -
1,2,3,4,5
17 Degree
Diameter - 4.5
Facial Heights -2.25,3,4
30 Degree
Diameter - 3.5,4.5 | Straight
Diameter - 4.7
Facial Heights -
1.5,2.5,3,4,5
17 Degree
Diameter - 5.3
Facial Heights -2,3
30 Degree
Diameter - 5.4
Facial Heights - 2,3 | Straight
Diameter - 4.7
Facial Heights -
1,2,3,4,5,6
17 Degree
Diameter - 5.3
Facial Heights -2,3
30 Degree
Diameter - 5.4
Facial Heights - 2,3 |
| | | Facial Heights - 3,4,5 | | |
| PEEK temporary
abutments Straight | Diameter - 4.5
Facial Heights - 1,2,3 | Temporary PEEK
abutments
Diameter -
3.0,3.5,4.5,5.7
Facial Heights - 3 | | |
| PEEK temporary
abutments Anatomic | Diameter - 4.5
Facial Heights - 1,2,3 | | Temporary PEEK
abutments
Diameter - 5.4
Facial Heights - 1,2,3 | |
| Ball attachments | Heights - 1,2,3,4,5,6 | Ball attachments
Diameter - 4.5
Facial Heights - 1,3,5 | Titanium Ball
attachments
Heights - 0.5,2,3,4,5,6 | Titanium Ball
attachments
Heights - 1,2,3,4,5,6 |
17
18