(437 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 is described as an endosseous implant that provides support for prosthetic devices to restore patients' esthetics and chewing function, which is a therapeutic purpose.
No
Explanation: The device description clearly states that the IDCAM Dental Implant is an endosseous implant intended to provide support for prosthetic devices, such as an artificial tooth, to restore esthetics and chewing function. It is a physical implant for treatment, not a tool for diagnosis.
No
The device description clearly details physical components made of titanium alloy, including implants, abutments, and healing caps, which are surgically placed. This indicates a hardware medical device, not software only.
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 IDCAM Dental Implants are surgically placed in the jaw to support prosthetic devices and restore function. This is a direct medical intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical components of the implant system (implants, abutments, healing caps), their materials, and their designs. This aligns with a surgical implant device, not a diagnostic kit or instrument.
- Performance Studies: The performance studies described focus on mechanical strength (fatigue testing), surface properties, biocompatibility, sterilization, and packaging integrity. These are typical evaluations for implantable medical devices, not IVDs which would focus on analytical and clinical performance related to detecting or measuring substances.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The IDCAM Dental Implant system does not perform any such function.
N/A
Intended Use / Indications for Use
IDCAM 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 and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading, These implants can also be used for loading after a conventional healing period.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.
All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.
ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.
PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.
Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.
Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).
Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. IDCAM implants exhibited a run out limit equivalent to other implant systems. Surface modification information was provided per the FDA Guidance Document for Endosseous Dental Implants and Abutments. Surface analysis and cytotoxicity testing per ISO 10993-5 was done to show the surface treatment does not adversely change the biocompatibility of the materials are ones common in dental implant systems and are appropriate materials for devices used with dental implants. Implants and abutments are made of titanium alloy which meets ASTM F136. Sterilization validation was conducted on the implants per ISO 11137-1,-2,and -3. Abutment steam sterilization validation was done per ISO 17665-2 and ANSI/AAMI ST79. Package integrity testing and accelerated aging were conducted per ISO 11607-1 and -2. 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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. 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.
Implants Diffusion International % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K200329
Trade/Device Name: IDCAM Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 18, 2021 Received: March 23, 2021
Dear Angela Blackwell:
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 medical devices and radiation-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.
Andrew I. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200329
Device Name IDCAM Dental Implants
Indications for Use (Describe)
IDCAM 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 and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading, These implants can also be used for loading after a conventional healing period.
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) |
|---|---|
| ☑ | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary April 21, 2021 IDCAM Dental Implants K200329
Name and address: Implants Diffusion International 23 rue Emile Zola Montreuil France 93100 Contact Person: Rony Boukhris Phone Number: +33 (0) 148707048 Name of device: IDCAM Dental Implants Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA
Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description: The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.
All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.
ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival
4
heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.
PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.
Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.
Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).
Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.
Indications for Use: IDCAM 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. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They
5
are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.
Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. IDCAM implants exhibited a run out limit equivalent to other implant systems. Surface modification information was provided per the FDA Guidance Document for Endosseous Dental Implants and Abutments. Surface analysis and cytotoxicity testing per ISO 10993-5 was done to show the surface treatment does not adversely change the biocompatibility of the materials are ones common in dental implant systems and are appropriate materials for devices used with dental implants. Implants and abutments are made of titanium alloy which meets ASTM F136. Sterilization validation was conducted on the implants per ISO 11137-1,-2,and -3. Abutment steam sterilization validation was done per ISO 17665-2 and ANSI/AAMI ST79. Package integrity testing and accelerated aging were conducted per ISO 11607-1 and -2. Endotoxin testing according to USP 161 was conducted.
Primary Predicate Device: SpiralTech Dental Implant System Ultimate Conical K170372 Reference Predicates: Cortex K090709 and K163385
Substantial Equivalence:
| Implant System
Comparison Table | ID CAM Dental
Implants (Subject
Device) | SpiralTech Dental
Implant System
K170372
Ultimate Conical |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | IDCAM 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. | 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
patient's esthetics and
chewing function.
Spiraltech implants
are intended for single |
| | IDCAM implants are | or multiple unit |
| | intended for single or | restorations on |
| | multiple unit | splinted or non- |
| | restorations on | splinted applications. |
| | splinted or non- | The implants ESi |
| | splinted applications. | Dynamic and Ultimate |
| | | are intended for |
| | They are intended for | immediate loading |
| | immediate loading | when good primary |
| | when good primary | stability is achieved,
and with appropriate |
| | stability is achieved, | occlusive loading. |
| | and with appropriate | These implants [along |
| | occlusive loading. | with Premium and |
| | These implants can | One Piece] can also be |
| | also be used for | used for loading after |
| | loading after a | a conventional healing |
| | conventional healing | period. |
| | 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. |
| Material | Ti6Al4V | Ti6Al4V |
| | IDCAM M | |
| Diameter of Implants | 4.2, 5.2 | 3.0, 3.5, 4.3, 5.0, 6.0 |
| Implant Lengths | 8.5, 9.4, 11.4, 14.4 | 8, 10, 11.5, 13, 15
(3.0mm diameter not
in 8 length) |
| Surface Treatment | SLA | SLA or RBM |
| Sterilization of Implants | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation |
| Sterilization of abutments | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them |
| Connection | Conical | Conical |
| Spiral Implant Design | IDCAM M | Ultimate Conical |
| ISO 14801 Fatigue Test | Run out limit is the same or higher than those of other implant systems | Run out limit is comparable to other implant systems. |
| IDCAM ST | | |
| Diameter of Implants | 3.7, 3.9, 4.2, 5.2 | 3.0, 3.5, 4.3, 5.0, 6.0 |
| Implant Lengths | 9.4, 11.4, 14.4 | 8, 10, 11.5, 13, 15 (3.0mm diameter not in 8 length) |
| Surface Treatment | SLA | SLA or RBM |
| Sterilization of Implants | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation |
| Sterilization of abutments | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them |
| Connection | Conical | Conical |
| Spiral Implant Design | IDCAM ST | Ultimate Conical |
| ISO 14801 Fatigue Test | Run out limit is the same or higher than those of other implant systems | Run out limit is comparable to other implant systems. |
IDCAM Dental Implants are substantially equivalent to SpiralTech Dental Implant System in indications for use, materials, design, and fatigue performance,
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7
| Conical Implant
Parts | IDCAM Dental
Implants | SpiralTech Dental
Implant System
Conical
Connection Parts | Cortex K090709
and K163385
Conical
Connection
Parts |
|--------------------------|--------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|
| Cover screw | Cover screw for
IDCAM 3.6mm
diameter | Cover screw NP
and RP | |
8
| Abutment screw | IDCAM and
IDUnit 3.6mm
abutment screws | NP and RP
abutment screws | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Multi-Unit
Abutments* | IDUnit 3.6mm
diameter at
platform 4.9mm
diameter at top
of shoulder
abutments in
gingival heights of
1,2.5, 4, and 6
mm | | NP, RP, and WP
Multi-unit
abutments in
heights of 1, 2, 3,
4, and 5 mm |
| 17° Multi-Unit
Abutments * | IDUnit 17° Multi-
Unit Abutments
3.6mm diameter
at platform
4.9mm diameter
at top of shoulder
in gingival heights
of 1.35,3.02, 5
mm | | NP and RP 18°
Multi-Unit
Abutments
in heights of 1, 2,
3, 4, 5 mm |
| 30° Multi-Unit
Abutments * | IDUnit 30° Multi-
Unit Abutments
3.6mm diameter
at platform
4.9mm diameter
at top of shoulder
in gingival heights
of 1,3.01, 5 mm | | NP and RP 30°
Multi-Unit
Abutments
in heights of 1, 2,
3, 4, 5 mm |
| Ball
attachments* | 3.5 mm diameter
at platform in
gingival heights of
1, 2.5, 4, and
6mm | NP and RP Ball
attachments in
heights of
1,2,3,4,5, and
6mm | |
| Healing Caps NP | Cylindrical
Healing Cap
Narrow 3.2mm
diameter in
3.5,5.5 mm
gingival heights | NP Healing Cap in
2,3,4,5 and 6 mm
height | |
| Healing Caps RP | Cylindrical
Healing Cap
Regular 4mm | RP Healing Cap in
2,3,4,5, and 6
mm height | |
| | diameter in 2,4, 6
and 8 mm
gingival heights | | |
| Healing Cap WP | Cylindrical
Healing Cap Wide
5mm diameter in
2, 4, 6, 8mm
gingival heights | | 5.8mm Healing
cap in 3,4,5,6
mm |
| Conical Profile
Healing Cap
Regular | 3.6mm diameter
at platform 4mm
cone top
diameter and 6
mm gingival
height | NP Healing Cap in
2,3,4,5 and 6 mm
height | |
| Conical Profile
Healing Cap Wide | 3.6mm diameter
at platform 6mm
cone top
diameter and 6
mm gingival
height | NP Healing Cap in
2,3,4,5 and 6 mm
height | |
| Healing Cap for
Multi-Unit | IDUnit healing
cap | | Titanium healing
cap for multi-
unit 5.0mm
diameter 4.8mm
height |
| Straight
Abutment | Morse taper cone
straight
abutment
3.6,4.2mm
diameter at
platform
gingival heights of
1.4, 3,5 mm | RP Flat Standard
Abutment with
height of 6,7,9
and 11 mm | |
| WP Shoulder
Abutment | Morse taper
shouldered
straight cone
abutment 5.4mm
diameter at
upper platform
3.6 mm diameter
at platform
bottom gingival | NP and RP Flat
with straight
shoulder
abutment in
heights of 1,2,
and 3 mm | WP anatomic
abutment
5.8mm diameter
in heights of 1, 2,
3, and 4mm |
9
10
| NP and RP 7°
Abutment | heights of 1.3,2.2
3.2, 5 mm
Height between
platform top and
bottom 3.7 +
gingival height
Morse taper 7°
angled cone
abutment
3.6 and 4.2mm
diameter with
gingival heights of
1.4,3,5 mm | NP and RP 15°
Abutment with
heights of 1,2,3
mm | NP and RP 15°
Anatomic
Abutment with
heights of 1,2,3,
4 mm |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| WP 7° Abutment
with shoulder | Morse taper 7°
angled cone
abutment with
shoulder
5.4 mm diameter
at upper platform
3.6mm diameter
at platform
bottom
gingival heights of
0.9,3,5 mm
Height between
platform top and
bottom 3.7 +
gingival height | | WP 15°
Anatomic
Abutment with
heights of 1,2,3,
4 mm |
| NP and RP 15°
Abutment | Morse taper 15°
angled cone
abutment
3.6 and 4.2mm
diameter with
gingival heights of
1.63, 3, 5 mm | NP and RP 15°
Abutment with
heights of 1,2,3
mm | NP and RP 15°
Anatomic
Abutment with
heights of 1,2,3,
4 mm |
| WP 15°
Abutment with
shoulder | Morse taper 15°
angled cone
abutment with
shoulder
5.4 mm diameter
at upper platform
3.6mm diameter
at platform
bottom | | WP 15°
Anatomic
Abutment with
heights of 1,2,3,
4 mm |
| NP and RP 23°
Abutment | gingival heights of
0.9, 2.35, 3.30,
5.03 mm
Height between
platform top and
bottom 3.7 +
gingival height | NP and RP 25°
Abutment with
heights of 1,2,
and 3mm | NP and RP 25°
Anatomic
Abutment with
heights of 2,3, 4
mm |
| | Morse taper 23°
angled cone
abutment
3.6 and 4.2mm
diameter gingival
heights of 1.63, 3,
5 mm | | |
| WP 23°
Abutment with
shoulder | Morse taper 23°
angled cone
abutment with
shoulder
5.4 mm diameter
at upper platform
3.6mm diameter
at bottom of
platform
gingival heights of
0.9, 2.35, 3.3,
5.03 mm
Height between
platform top and
bottom 3.7 +
gingival height | | WP 25°
Anatomic
Abutment with
heights of 1,2,3,
4 mm |
| Locator
Abutments * | IDLoc attachment
3.6mm diameter
at platformi
gingival heights of
2.5,4, 5.5, and 7.5
mm | IPI NP and RP in
heights of
1,2,3,4,5 and 6
mm | |
| WP
Straight
Abutment with
shoulder | Plan straight
abutment with
shoulder 5.4mm
diameter at
shoulder top
3.6mm diameter
at shoulder
bottom | | WP anatomic
abutment
5.8mm diameter
in heights of 1, 2,
3, and 4mm |
| | gingival heights of
1.5 and 3mm | | |
| WP 15° angled
abutment with
shoulder | Plan 15° angled
abutment with
shoulder 5.4mm
diameter at
shoulder top
3.6mm diameter
at shoulder
bottom
gingival heights of
1.5 and 3mm | WP 15°
Anatomic
Abutment with
heights of 1,2,3,
4 mm | |
| WP 23° angled
abutment with
shoulder | Plan 23° angled
abutment with
shoulder 5.4mm
diameter at
shoulder top
3.6mm diameter
at shoulder
bottom
gingival heights of
1.5 and 3mm | WP 25°
Anatomic
Abutment with
heights of 1,2,3,
4 mm | |
| Temporary
Abutments | 3.6mm diameter
provisional
abutments in
rotational
(gingival height
1.5, post height
7.5), non-
rotational
(gingival height
1.5, post height
7.5, 4.8mm
diameter at top
of shoulder), non-
rotational tall
(gingival height
1.5mm, post
height 12.5mm,
4.0mm diameter
at top of
shoulder) and
IDUnit (4.9 mm | Nobel Biocare
K161435
Temporary Snap
Abutments
engaging, non-
engaging, and
multi-unit | |
| diameter at base, post height 10.5) | | | |
11
12
13
*These models of abutments are not for single crown use.
Conclusion:
IDCAM Dental Implants are substantially equivalent to SpiralTech Dental Implant System. They both have the same indications for use, are of the same material, and have conical connections. Performance testing demonstrates substantial equivalence to the identified predicate devices. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutments not found in the predicate device system are found in the reference device system. The design and size differences between predicate or reference devices and the subject devices are only minor differences in geometry and size so given the use, materials and technology is the same they do not change the substantial equivalence.