(422 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical and biological properties.
No
The device is described as an internal hex implant system used for surgical and restorative applications to support prosthetic devices and restore chewing function, which is a structural and functional restoration, not a therapeutic treatment for disease.
No
Explanation: The device, the ABC Dental Implant System, is described as being used for "surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function." This description indicates it is a therapeutic device intended for treatment (restoring chewing function), not for diagnosing a condition or disease.
No
The device description explicitly details physical components made of titanium alloy, including implants, abutments, and healing caps, which are hardware. The performance studies also focus on physical properties like fatigue strength and biocompatibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct medical intervention on the patient's body.
- Device Description: The description details the physical components of a dental implant system (implants, abutments, healing caps) made of titanium alloy. These are physical devices implanted into the body.
- Performance Studies: The performance studies focus on mechanical strength (fatigue testing), biocompatibility, sterilization, and packaging integrity. These are typical tests for implantable medical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health condition, or disease. The device itself is the treatment/support structure.
IVDs are used outside the body to examine specimens and provide diagnostic information. This device is implanted inside the body for therapeutic and restorative purposes.
N/A
Intended Use / Indications for Use
The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
ABC Dental Implant System is an internal hex implant system with one model of implant at this time. ABC dental implant is a slightly tapered cylindrical internal hex implant with micro-rings at the implant neck, which comes in 3.3. 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13, and 16. The 5.0 and 6.0 diameter implants do not come in a length of 16mm.
All implants and abutments are made of ASTM F136 Ti 6A1 4V ELI. The implants have a grit blasted and acid etched surface. All types of abutments can be used with all implants.
Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. Straight abutments come in 5. 7, 9, or 11mm leneths and shouldered straight abutments come 1, 2, 3, or 4mm in height. Wide straight shoulder abutments come in heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 5, 7, 9, 11 mm. Smooth straight wide abutments come in lengths of 5, 7, 9, and 11 mm and the grooved version comes only in 9mm. 15° anatomic angulated abutments come in heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in heights of 1, 2, or 3mm.
Straight multi-unit abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in heights of 0.5, 1.5, or 2.5 mm. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Straight multi-unit mounted dentures can only be removed by the dentist, but dentures mounted on flat abutments or ball attachments can be removed by the patient.
Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in heights of 2, 3, 4, and 5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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)
Non-Clinical Performance Testing: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. ABC implants exhibited a run out limit about the same or higher than other implant systems. Surface analysis was done to show the surface treatment does not adversely change the cytotoxicity of the materials. Biocompatibility testing was performed on the implants and abutments, and both substrates were found not to have cytotoxic potential, according to the requirements of ISO 10993-5.
All the materials are ones common in dental implants and abutments and abutments are made of titanium alloy which meets ASTM F136. Sterilization was conducted on the implants. Abutment steam sterilization was done. Package integrity testing and accelerated aging were conducted. Endotoxin testing according to USP 161 was conducted.
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
§ 872.3640 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 23, 2021
Abracadabra Implants Ltd Vladislav Dvoyris VP Marketing and Clinical Education 12 Hacharoshet St. Or-Yehuda 6037580 ISRAEL
Re: K202092
Trade/Device Name: ABC Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 23, 2021 Received: August 27, 2021
Dear Vladislav Dvoyris:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202092
Device Name ABC Dental Implant System
Indications for Use (Describe)
The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.
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
510k Summary, September 18, 2021 ABC Dental Implant System - K202092
Name and address: Abracadabra Implants Ltd 12 Hacharoshet St Or Yehuda, Israel, 6037580 Contact Person: Daniel Younisian Phone Number: +972 52 600 8222 Name of device: ABC Dental Implant System Classification Name: Endosseous dental implant CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA
Trade name information: The ABC Dental Implant System is intended to be marketed under the trade name "ABraCadabra Implants".
Primary Predicate Device: Alpha-Bio Tec® Dental Implant System (SPI DFI NEO) -K063364 Reference Devices: ARDS Dental Implants (Classic and Premium CIC) - K071803
Device Description: ABC Dental Implant System is an internal hex implant system with one model of implant at this time. ABC dental implant is a slightly tapered cylindrical internal hex implant with micro-rings at the implant neck, which comes in 3.3. 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13, and 16. The 5.0 and 6.0 diameter implants do not come in a length of 16mm.
All implants and abutments are made of ASTM F136 Ti 6A1 4V ELI. The implants have a grit blasted and acid etched surface. All types of abutments can be used with all implants.
Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. Straight abutments come in 5. 7, 9, or 11mm leneths and shouldered straight abutments come 1, 2, 3, or 4mm in height. Wide straight shoulder abutments come in heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 5, 7, 9, 11 mm. Smooth straight wide abutments come in lengths of 5, 7, 9, and 11 mm and the grooved version comes only in 9mm. 15° anatomic angulated abutments come in heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in heights of 1, 2, or 3mm.
Straight multi-unit abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in heights of 0.5, 1.5, or 2.5 mm. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Straight multi-unit mounted dentures can only be removed by the dentist, but dentures mounted on flat abutments or ball attachments can be removed by the patient.
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Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in heights of 2, 3, 4, and 5 mm.
Indications for Use:
The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.
Substantial Equivalence:
ABC Dental Implant System is substantially equivalent to Alpha-Bio Tec Dental Implant System in indications for use, materials, design, and fatigue performance.
| Characteristic | ABC Dental Implants
(Bolero) | Alpha-Bio Tec® Dental
Implant System (SPI DFI
NEO) | ARDS Dental Implants
(Classic and Premium CIC) | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indication | The ABC Dental Implants
System is indicated for use in
surgical and restorative
applications for placement in
the bone of the upper or lower
jaw to provide support for
prosthetic devices, such as
artificial teeth, to restore the
patient's chewing function.
The ABC Dental Implants
System is also indicated for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading | The Alpha-Bio Dental Implant
System® is
indicated for use in surgical
and restorative applications
for
placement in the bone of the
upper or lower jaw to provide
support
for prosthetic devices, such as
artificial teeth, to restore
the patient's chewing function.
The Alpha-Bio Dental Implant
System® is indicated also for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading. | ARDS dental implants are
indicated for use in surgical
and restorative
applications for placement in
the bone of the upper and
lower jaw to provide
support for prosthetic devices
to restore the patient's
chewing function. ARDS
dental implants are indicated
for two-stage surgery. | |
| Site/Bone type | Bolero is suitable for dense
bone D1 / D2 and soft bone
D3 / D4 in the upper or lower
jaw. | SPI does not state a specific
site or bone site indication.
DFI is referred by the
manufacturer as Suitable for
all bone types, ideal for use in
bone types D2 and D3.
NEO is referred by the
manufacturer as Suitable for
all bone types D2, D3 and D4. | Classic will optimally be used
for softer bone when bone
compression around the
implant can be done
Premium recommended to be
used also for harder and more
condensed bones such as type
D1
CIC is referred by the
manufacturer as Suitable for
all bone types, ideal for use in
bone types D2 D3 and D4. | |
| Population | Edentulous and partially
dentate patients | Edentulous and partially
dentate patients | Edentulous and partially
dentate patients | |
| Performance | Intended to provide support
for prosthetic devices, such as
artificial teeth, in order to | Intended to provide support
for prosthetic devices, such as
artificial teeth, in order to | Intended to provide support
for prosthetic devices, such as
artificial teeth, in order to | |
| Characteristic | ABC Dental Implants
(Bolero) | Alpha-Bio Tec® Dental
Implant System (SPI DFI
NEO) | ARDS Dental Implants
(Classic and Premium CIC) | |
| | restore the patients' chewing
function. | restore the patients' chewing
function. | restore the patients' chewing
function. | |
| Device Design | Screw-shaped Titanium dental
implant -
Bolero parallel | Screw-shaped Titanium dental
implant
SPI Conical
DFI parallel
NEO Conical | Screw-shaped Titanium dental
implant
Classic - Conical
Premium - Parallel
CIC- Conical | |
| Placement Method | One and two-stage procedure. | One and two-stage procedure. | Two-stage procedure. | |
| Material | Ti-6Al-4V Eli ASTM F136
(Grade 5) | Ti-6Al-4V Eli (Grade 5) | Ti-6Al-4V Eli (Grade 5) | |
| Dimensions and
tolerances Diameter
(mm) | Bolero - 3.3, 3.75, 4.2, 5mm
±0.1mm | SPI-3.3, 3.75, 4.2, 5, 6mm
±0.1mm
DFI- 3.3, 3.75, 4.2, 5mm
±0.1mm
NEO- 3.75, 4.2, 5.0mm
±0.1mm | Classic - 3.3, 3.75, 4.2, 5,
6mm ±0.1mm
Premium -3.3, 3.75, 4.2, 5,
6mm ±0.1mm
CIC- 3.5mm ±0.1mm | |
| Dimensions and
tolerances length
(mm) | 6, 8, 10, 11.5, 13,
16mm±0.1mm | 6, 8, 10, 11.5, 13,
16mm±0.1mm | 8, 10, 11.5, 13, 16mm ±0.1mm | |
| Anti-rotational
features-internal
external hexagonal.
etc. | internal hexagonal | internal hexagonal | internal hexagonal | |
| Device features | Self-tapping and self-
condensing tapered titanium
screw implant | Self-tapping and self-
condensing tapered titanium
screw implant with variable
thread design | Self-tapping titanium screw
implant with dual thread
design | |
| Flat axial surface
features on the
implant | None | None | None | |
| Internal hex.
threads(inch) | 1#72 | 1#72 | 1#72 | |
| Abutment
connection | Hexagon + screw | Screw or hexagon + screw | Screw or hexagon + screw | |
| Surface treatment | Sandblasting, followed by
cleaning by acid treatment | Sandblasting, followed by
cleaning by acid treatment | Sandblasting, followed by
cleaning by acid treatment | |
| Packaging | Double vial | Vial and a Blister | Double vial | |
| Implant Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | |
| Components | The ABC Dental Implant
System consists of one and
two-stage endosseous form
dental implants with an
internal hexagonal
connection; cover screw and
healing caps; abutment
systems and superstructures;
surgical instruments (). | The Alpha-Bio Dental Implant
System® consists of one and
two-stage endosseous form
dental implants, with an
internal hexagonal connection;
cover screws and healing caps;
abutment systems and
Superstructures; surgical
instruments (). | The Alpha-Bio Dental Implant
System® consists of one and
two-stage endosseous form
dental implants, with an
internal hexagonal connection;
cover screws and healing caps;
abutment systems and
Superstructures; surgical
instruments (*). | |
| Abutments
[refer to abutment
comparison in the
rows below] | Straight & up to 25° | Straight & up to 25° | Straight & up to 25° | |
| Abutment Type/Dimensions | | ABC | Alpha Bio | ARDS Dental Implants |
| | Standard
abutment | screw thread - 1#72 inch.
Diameter: 3.8, 4.5, 5.5 | screw thread - 1#72 inch.
Diameter: 3.5, 4.5, 5.5 mm | screw thread - 1#72 inch.
Diameter: Slim - 3.8mm
Normal - 4.5mm,
Wide - 5.5,6.3mm |
| | Standard
abutment
with
shoulder | screw thread - 1#72 inch.
Diameter:3.8, 4.5, 5.5mm.
Shoulder height: 1, 2, 3,
4mm. | screw thread - 1#72 inch.
Diameter: 4.5, 5.5mm
Shoulder height: 1,
2,3,4mm. | screw thread - 1#72 inch.
Diameter: normal -
4.5mm, wide - 5.5mm.
Shoulder height 1-4mm |
| | 15° Angular
abutment | screw thread - 1#72 inch.
Diameter: 4.5, mm. | screw thread - 1#72 inch.
Diameter: 4.5, mm. | screw thread - 1#72 inch.
diameter- normal-
4.5mm, wide- 5.5 mm |
| | 25° Angular
abutment | screw thread - 1#72 inch.
Diameter: 4.5, mm. | screw thread - 1#72 inch.
Diameter: 4.7mm. | screw thread - 1#72 inch.
diameter- 4.7mm |
| | 15° Angular
abutment
with
shoulder | screw thread - 1#72 inch.
Diameter: 4.5, mm.
Shoulder height 1,2,3,4mm. | screw thread - 1#72 inch.
Diameter: 4.7mm.
Shoulder height 1,2,3mm. | screw thread - 1#72 inch.
Diameter -4.5 mm.
Shoulder height 1-2mm |
| | 25° Angular
abutment
with
shoulder | Connection: Internal
hexagon - 2.43 mm
diameter,
screw thread - 1#72 inch.
Diameter:4.5, mm.
Shoulder height 1,2,3,4mm. | Connection: Internal
hexagon - 2.43 mm
diameter.
screw thread - 1#72 inch.
Diameter: 4.7mm.
Shoulder height 1,2,3mm. | Connection: Internal
hexagon - 2.43 mm
diameter,
screw thread - 1#72 inch.
Diameter - 4.7 mm.
Shoulder height 1-2mm |
| | Standard
Healing
Cap | 4.6 mm in diameter
L: 2-8mm | 4.6 mm in diameter
L: 2-7mm | 4.5 mm in diameter
L: 3-5mm |
| | Standard
Healing
Cap Narrow | 3.8 mm in diameter
L: 2-7mm | 3.85 mm in diameter
L: 3-5mm | 3.8 mm in diameter
L: 3-5mm |
| | Standard
Healing
Cap Wide | 5.5 mm in diameter
L: 2-7mm | 5.5 mm in diameter
L: 3-5mm | 4.7 mm in diameter
L: 3-5mm |
| | Standard
Healing
Cap Extra
Wide | 6.3 mm in diameter
L: 2-5mm | 6.3 mm in diameter
L: 3-5mm | N/A |
| | ABC | Alpha Bio | ARDS Dental Implants | |
| Standard
Ball
Attachment | H: 1-7mm | L: 0.5-6mm | H: 1-5mm | |
| Standard
Multi Unit | L: 1-4mm | L: 2.1 | L: 1-5mm | |
| Surface treatment | None | None | None | |
5
6
7
Non-Clinical Performance Testing: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. ABC implants exhibited a run out limit about the same or higher than other implant systems. Surface analysis was done to show the surface treatment does not adversely change the cytotoxicity of the materials. Biocompatibility testing was performed on the implants and abutments, and both substrates were found not to have cytotoxic potential, according to the requirements of ISO 10993-5.
All the materials are ones common in dental implants and abutments and abutments are made of titanium alloy which meets ASTM F136. Sterilization was conducted on the implants. Abutment steam sterilization was done. Package integrity testing and accelerated aging were conducted. Endotoxin testing according to USP 161 was conducted.
Conclusion - Statement of Substantial Equivalence:
ABC Dental Implant System is substantially equivalent to Alpha-Bio Tec Dental Implant. System. They both have the similar indications for use, are of the same material, and have internal hexagon connections.
Performance testing demonstrates that the subject device exhibits equivalent performance to the predicate device. They use the same type of technology for their surface treatments and manufacturing. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing showed that the subject device performs as well as the predicate device. Therefore, the data provided in this submission shows that the subject device is substantially equivalent to the predicate.