(149 days)
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.
The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.
The provided text is a 510(k) Summary for Blue Sky Bio CAD-CAM Abutments, which is a dental device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria and study results for a novel AI/ML device.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.
The text describes:
- Device: Blue Sky Bio CAD-CAM Abutments (dental implant components).
- Indications for Use: To be used with Blue Sky Bio endosseous dental implants to support single-unit or multi-unit prosthetic restorations. Digitally designed abutments are sent to a Blue Sky Bio validated milling center for manufacture.
- Performance Data (Non-clinical): Mentions sterilization validation (ISO 17665-1, ISO 17665-2), biocompatibility testing (ISO 10993-5, ISO 10993-12), and static and dynamic compression-bending testing (ISO 14801).
- Clinical Data: Explicitly states "No clinical data were included in this submission."
- Substantial Equivalence: Compares the subject device to various predicate and reference devices in terms of indications for use, design principles, materials, physical dimensions, packaging, and sterilization methods. The mechanical testing (ISO 14801) is mentioned as mitigating minor design differences.
Without information specific to an AI/ML device, I cannot fulfill the request to describe acceptance criteria and a study proving an AI/ML device meets them, nor can I populate the table or provide details on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.
Blue Sky Bio, LLC % Kevin Thomas Vice President, Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K202026
Trade/Device Name: Blue Sky Bio CAD-CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 17, 2020 Received: December 18, 2020
Dear Kevin Thomas:
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.
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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 (OS) 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 Steen Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202026
Device Name
Blue Sky Bio CAD-CAM Abutments
Indications for Use (Describe)
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for multi-unit prosthetic restorations.
All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.
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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510(k) Summary K202026 Blue Sky Bio, LLC Blue Sky Bio CAD-CAM Abutments
December 17, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Blue Sky Bio, LLC800 Liberty DriveLibertyville, IL 60048 |
|---|---|
| Telephone | +1 718-376-0422 |
| Fax | +1 888-234-3685 |
| Official Contact | Michele Kupcso, Vice President of RA/QA |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 |
| Telephone | +1 858-792-1235 |
| Fax | +1 858-792-1236 |
| kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Blue Sky Bio CAD-CAM Abutments |
|---|---|
| Common Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, AnesthesiaRespiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices
K180536, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC
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K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K051507, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K183518, Preat Abutments, Preat Corporation K151984, Milling Abutment For CAD/CAM, Thommen Medical AG
INDICATIONS FOR USE STATEMENT
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments.
For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half.
Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe).
Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. The design parameters for the CAD-CAM zirconia superstructure for the Titanium Base Abutments are:
Minimum wall thickness - 0.5 mm Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.70 mm Maximum angulation Straight Titanium Bases - superstructure maximum angle - 30° Angled Titanium Bases - superstructure maximum angle - 15° The maximum angulation of the final abutment - 30°
Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. The maximum angulation of the final abutment is up to 30°.For the second method, the Cobalt Base Abutments
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(Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques.
Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. The maximum angulation of the Cobalt Base Abutments (Angled 15°) is up to15°; the final abutment will have an angulation of up to 30°. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment.
The design parameters for the CAD-CAM zirconia superstructure for the Cobalt Base Abutments are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.7 mm Maximum angulation Cobalt Base Abutments (Straight) - superstructure maximum angle - 30° Cobalt Base Abutments (Angled 15°) - superstructure maximum angle - 15° The maximum angulation of the final abutment - 30°
For Cobalt Base Abutments (Straight) that are finalized to a one-piece abutment by lost wax casting, the design parameters are:
Minimum wall thickness – 0.5 mm: Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.7 mm Maximum angulation - 0°, straight final abutment only
Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The design parameters for customized abutments fabricated from Titanium Blank Abutments are:
Minimum wall thickness - 0.4 mm Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.7 mm Maximum angulation - 30°
The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034.
All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.
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PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 17665-2 (referenced from Blue Sky Bio submissions K073713 and K153064); biocompatibility testing according to ISO 10993-5 and ISO 10993-12: and static and dynamic compression-bending testing according to ISO 14801. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The primary predicate device K191986 is for support of substantial equivalence of the Indications for Use statement and for the use of the Co-Cr alloy material. The reference device K180536 is for support of substantial equivalence of the CAD-CAM abutment designs. The reference devices K102034, K060957, and K051507 are for support of substantial equivalence of the identical Blue Sky Bio dental implant interface connections and platforms. The reference device K183518 is for support of substantial equivalence of the performance testing data. The reference device K151984 is for support of substantial equivalence of the subject device maximum gingival height of 6.7 mm.
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. All are intended to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the to the primary predicate device and the reference devices listed above; differences in language of the Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.
Similarities between the IFUS for the subject device and the primary predicate K191986 include wording regarding support for maxillary or mandibular prosthetic restorations and the requirement for use validated milling centers. The minor differences between the IFUS for the subject device and the primary predicate K191986 include specific device names and wording dental implant compatibilities in the IFUS for K191986.
The minor differences between the IFUS for the subject device and the reference device K180536 include wording regarding dental implants (not applicable to the subject device), and wording about the specific abutment designs in K180536. Similarities between the IFUS for the subject device and the reference device K180536 include wording regarding single-unit and multi-unit restorations and the requirement for use validated milling centers.
The reference devices K102034, K060957, and K051507 are for substantial equivalence of the identical Blue Sky Bio dental implant interface connections and platforms, the reference device K183518 is for
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support of substantial equivalence of the performance testing data, and the reference device K151984 is for support of substantial equivalence of the subject device maximum gingival height of 6.7 mm. Differences among the IFUS for the subject device and these reference devices are wording the implant components included in K102034, K060957, K051507, and K151984; the relevant similarities include wording concerning prosthetic support of single-unit and multi-unit restorations. Similarities between the IFUS for the subject device and K183518 include wording on the intended use for and single-unit and multi-unit restorations and the requirement for use validated milling centers. Minor differences between the IFUS for the subject device and K183518 include specific wording about base abutments and the listing of compatible implant systems. None of these minor differences impact substantial equivalence because all IFUS express an equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
The subject device abutments have interface connections and platforms that are identical to the compatible Blue Sky Bio dental implants cleared in the reference devices K102034, K060957, and K051507. The subject device includes designs for compatible Blue Sky Bio implant platforms ranging from 2.8 mm (Mini) to 4.5/5.0 mm.
The subject device Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments designs are substantially equivalent in material, design, and ranges of sizes to the corresponding abutments in K180536, K191986, K183518, and K151984. The maximum gingival height for the subject device abutments is 6.7 mm, which is substantially equivalent to the gingival height of the CAD-CAM abutments cleared in K151984.
Minor differences in the design parameters for zirconia copings to be used with the subject device base abutments and the predicate device base abutments (minimum wall thickness, maximum gingival height, maximum angulation) are mitigated by mechanical testing performed in conformance with ISO 14801. Similarly, minor differences in the design parameters for the subject device blank abutments and the predicate device blank abutments also are mitigated by mechanical testing performed in conformance with ISO 14801.
The subject device includes abutments made of titanium alloy conforming to ASTM F136. The titanium alloy subject device components are manufactured from identical materials. in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in the reference devices K051507, K060957, and K102034. In addition, subject device titanium alloy abutments are anodized in various colors for ease of identification of the abutment platform. This anodization process is identical to the anodization process used on Blue Sky Bio abutments cleared in the reference device K102034.
The subject device also includes abutments made of cobalt-chromium alloy conforming to ASTM F1537. Substantial equivalence for the subject device Cobalt Base abutments is supported by use of the same material for abutments in the primary predicate device K191986. The subject device Titanium Base Abutments and Cobalt Base Abutments are to be used with copings fabricated from zirconia conforming to ISO 13356. This is the same material used for copings in the primary predicate device K191986.
Confirmatory biocompatibility testing for the subject device cobalt-chromium alloy and zirconia materials was performed according to ISO 10993-5 and ISO 10993-12.
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Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments, fabricated to the limits stated in the proposed labeling, in combination with previously-cleared compatible Blue Sky Bio implants have sufficient strength for their intended use.
Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact safety or effectiveness because these differences are related to the compatible implant designs and are mitigated by the mechanical performance testing.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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Table of Substantial Equivalence –Indications for Use Statement
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|---|---|
| K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC | K191986DESS Dental Smart SolutionsTerrats Medical SL | K180536Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K191986DESS Dental Smart SolutionsTerrats Medical SL | K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC | K060957Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC | K051507Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC | K183518Preat AbutmentsPreat Corporation |
| Blue Sky Bio CAD-CAM Abutments areintended to be used in conjunction withBlue Sky Bio endosseous dentalimplants in the maxillary or mandibulararch to provide support for single-unit ormulti-unit prosthetic restorations.All digitally designed abutments for usewith Blue Sky Bio CAD-CAMAbutments are intended to be sent to aBlue Sky Bio validated milling centerfor manufacture. | DESS Dental Smart Solutions abutmentsare intended to be used in conjunctionwith endosseous dental implants in themaxillary or mandibular arch to providesupport for prosthetic restorations.All digitally designed custom abutmentsfor use with Ti Base abutments or Pre-milled (Blank) abutments are to be sentto a Terrats Medical validated millingcenter for manufacture.For table of Compatible Implant Systemssee complete K191986 predicateliterature in this section. | Indications for Use for GM HelixImplants and conventional abutments:The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide supportfor prosthetic devices such as artificialteeth, to restore chewing function. It maybe used with single-stage or two-stageprocedures, for single or multiple unitrestorations, and may be loadedimmediately when good primary stabilityis achieved and with appropriate occlusalloading.Indications for Use for GM ExactTitanium Block for Medentika Holder:GM Exact Titanium Block forMedentika Holder is a titanium abutmentto be used in fabricating a full customabutment and placed onto Neodentdental implants to provide support forcustomized prosthetic restorations. TheGM Exact Titanium Block forMedentika Holder abutments areindicated for screw-retained singlerestorations or cement-retained single ormulti-unit restorations. All digitallydesigned abutments for use with the GMExact Titanium Block for MedentikaHolder are intended to be sent toStraumann for manufacture at avalidated milling center.Indications for Use for GM ExactTitanium Base abutments:Titanium Base Abutment is a titaniumbase placed onto Neodent dentalimplants to provide support forcustomized prosthetic restorations. It isused with a coping and crown, or crownalone, and is indicated for cement-retained single or multi-unit restorations,or screw-retained single restorations. Alldigitally designed copings and/or crownsfor use with the Neodent Titanium BaseAbutment System are intended to be sentto Straumann for manufacture at avalidated milling center.Indications for Use for Titanium Base Cfor GM Exact abutments:The Titanium Base C for GM Exactabutments is a titanium component thatis placed over Neodent implants toprovide support for custom prostheticrestorations, such as copings or crowns.It is indicated for single-tooth screw-retained restorations.All digitally designed copings and/orcrowns for use with the Titanium Base Cfor GM Exact abutments are to bedesigned using Sirona inLab software orSirona CEREC Software andmanufactured using a Sirona CEREC orinLab MC X or MC XL milling unit. | DESS Dental Smart Solutions abutmentsare intended to be used in conjunctionwith endosseous dental implants in themaxillary or mandibular arch to providesupport for prosthetic restorations.All digitally designed custom abutmentsfor use with Ti Base abutments or Pre-milled (Blank) abutments are to be sentto a Terrats Medical validated millingcenter for manufacture.For table of Compatible Implant Systemssee complete K191986 predicateliterature in this section. | Intended Use for Two-Piece ImplantSystems• For implantation into any area of thefully edentulous maxilla and mandiblefor the support of a removable or fixeddental prosthesis• For single tooth or multiple unitprosthesis• For single stage or two stage surgicalprocedure• For immediate placement andimmediate function when multiple unitsare splinted and for single units whenadequate initial stability is achieved intype I or type II bone and underappropriate occlusal loading. Multipleunits may be splinted with a bar. Inedentulous cases restored with a fixedprosthesis, four or more implants mustbe used.• Unsplinted narrow implants and angledabutments are not to be used in theposterior areas.• Taper Hex Implant System iscompatible with NobelActive implantsand prosthetics• Double Hex Implant System iscompatible with Astra double heximplants and prosthetics• Square Taper Implant System iscompatible with Straumann Bone-Levelimplants and ProstheticsIntended Use for One-Piece ImplantSystem• For implantation into any area of thefully edentulous maxilla and mandiblefor the support of a removable or fixeddental prosthesis• For single tooth or multiple unitprosthesis• For single stage surgical procedure• For immediate placement andimmediate function when multiple unitsare splinted and for single units whenadequate initial stability is achieved intype I or type II bone and underappropriate occlusal loading. Inedentulous cases four or more implantsmust be used• Overdenture Implants are intended forsupport of removable prosthesis. | Indications for Use:• For implantation into any area of thefully edentulous maxilla and mandiblefor the support of a removable or fixeddental prosthesis• For implantation into any area of thepartially edentulous maxilla andmandible for the support of a removableor fixed dental prosthesis• For single tooth or multiple unitprosthesis• For single stage or two stage surgicalprocedure• One piece implants for single stageprocedure only• For immediate placement andimmediate function when multiple unitsare splinted and for single units whenadequate initial stability is achieved intype I or type II bone and underappropriate occlusal loading. Multipleunits may be splinted with a bar. Inedentulous cases restored with a fixedprosthesis, four or more implants mustbe used. | Indications for Use:• For implantation into any area of thefully edentulous maxilla and mandiblefor the support of a removable or fixeddental prosthesis• For implantation into any area of thepartially edentulous maxilla andmandible for the support of a removableor fixed dental prosthesis• For single tooth or multiple unitprosthesis• For single stage or two stage surgicalprocedure• One piece implants for single stageprocedure only• For immediate placement andimmediate function when multiple unitsare splinted and for single units whenadequate initial stability is achieved intype I or type II bone and underappropriate occlusal loading. Multipleunits may be splinted with a bar. Inedentulous cases restored with a fixedprosthesis, four or more implants mustbe used. | Preat Abutments are intended to be usedin conjunction with endosseous dentalimplants in the maxillary or mandibulararch to provide support for single-unit ormulti-unit prosthetic restorations. TheTitanium Base abutments consists oftwo major parts. Specifically, thetitanium base and mesostructuredcomponents make up a two-pieceabutment.All digitally designed customabutments, superstructures, and/orhybrid crowns for use with TitaniumBase or Titanium Blank are to be sent toa Preat validated milling center formanufacture.For table of Compatible ImplantSystems see complete K183518predicate literature in this section. |
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | |
| K202026Blue Sky Bio CAD-CAMAbutmentsBlue Sky Bio, LLC | K191986DESS Dental Smart SolutionsTerrats Medical SL | K180536Neodent Implant System -GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K102034Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K060957Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K051507Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K183518Preat AbutmentsPreat Corporation | |
| Reason for Primary Predicate /Reference Device | Not applicable | Indications for Use StatementCo-Cr Base material | CAD-CAM abutment designs | Compatible identical implantinterface and platforms | Compatible identical implantinterface and platforms | Compatible identical implantinterface and platforms | Performance testing data |
| Product Codes | NHA | NHA | DZE, NHA | DZE, NHA | DZE | DZE | NHA |
| Intended Use | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla |
| Designs/Features | |||||||
| Abutment Design | Titanium Base AbutmentsCobalt Base AbutmentsTitanium Blank Abutments | Ti BaseCrCo BasePre-milled (Blank) Abutments | Titanium Base AbutmentsTitanium Block Abutments (Blanks) | Conventional one-piece abutments | Conventional one-piece abutments | Conventional one-piece abutments | Various designs including:Titanium Base AbutmentsTitanium Blank Abutments |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit |
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Abutment-Implant Interface | Internal | Internal | Internal | Internal | Internal | Internal | Internal |
| Abutment-ImplantPlatform Diameter (mm) | Mini (2.8)NP (2.8)RP (3.3)3.53.5/4.04.5/5.03.5 | 2.52 - 6.5 | Not applicable(Neodent GM line, Morse taperinternal connection) | Mini (2.8)NP (2.8)RP (3.3)3.53.5/4.04.5/5.0 | 3.5 | 3.0 – 6.5 | |
| 4.34.55.0NP (3.5)RP (3.5)WP (4.3) | 4.34.55.0 | NP (3.5)RP (3.5)WP (4.3) | |||||
| Prosthetic Platform Diameter | 3.9 mm - 6.5 mm | 4.5 mm - 6.5 mm | 4.65 mm, 5.5 mm | Not stated in 510(k) Summary | |||
| Base Abutments - Coping DesignParameters | |||||||
| Minimum wall thickness | 0.5 mm | 0.4 mm | Not stated in 510(k) Summary | 0.5 mm | |||
| Minimum post height | 4.0 mm | 4.2 mm | 4 mm | 4.0 mm | |||
| Minimum gingival height(of the coping) | 0.5 mm | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Not stated in 510(k) Summary | |||
| Maximum gingival height(of the coping) | 6.7 mm | 6.0 mm | Not stated in 510(k) Summary | 5.0 mm | |||
| Angulation of Finished Abutment | Up to 30° | 0° (straight only) | 20°, 30° | 0° (straight only) | |||
| Cement to bond coping to base | Multilink Hybrid AbutmentCement,(Ivoclar Vivadent AG) | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Not stated in 510(k) Summary | |||
| Blank Abutments – Final DesignParameters | |||||||
| Minimum wall thickness | 0.4 mm | 0.4 mm | Not stated in 510(k) Summary | 0.5 mm | |||
| Minimum post height | 4 mm | 4 mm | Not stated in 510(k) Summary | 4.0 mm | |||
| Minimum gingival height | 0.5 mm | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Not stated in 510(k) Summary | |||
| Maximum gingival height | 6.7 mm | 6.0 mm | Not stated in 510(k) Summary | 1.5 - 2.65 (varies by implant line) | |||
| Angulation of Finished Abutment | Up to 30° | 0° (straight only) | Up to 30° | Up to 30° | |||
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | |
| K202026Blue Sky Bio CAD-CAMAbutmentsBlue Sky Bio, LLC | K191986DESS Dental Smart SolutionsTerrats Medical SL | K180536Neodent Implant System –GM LineJJGC Indústria e Comércio deMateriais Dentários S.A. | K102034Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K060957Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K051507Blue Sky Bio Dental ImplantSystemBlue Sky Bio, LLC | K183518Preat AbutmentsPreat Corporation | |
| Materials | |||||||
| Abutment Materials | Titanium alloy, ASTM F136Cobalt-chromium alloy, ASTMF1537Copings:Zirconia, ISO 13356 | Titanium alloy, ASTM F136Cobalt-chromium alloy, ASTMF1537Copings:Zirconia, ISO 13356 | Titanium alloy, ASTM F136Materials for copings not stated in510(k) Summary | Titanium alloy, ASTM F136Materials for copings not applicable | Titanium alloy, ASTM F136Materials for copings not applicable | Titanium alloy, ASTM F136Materials for copings not applicable | Titanium alloy, ASTM F136Copings:Zirconia, ISO 13356 |
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Table of Substantial Equivalence – Technological Characteristics
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510(k) Summary
Page 9 of 9
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)