(93 days)
The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.
Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:
| Implant Brand and Type | Implant Platform Size |
|---|---|
| Implant Direct Legacy | 3.5mmD, 4.5mmD, 5.7mmD |
| Implant Direct ReActive | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlus | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlant | 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD |
| Implant Direct SwishPlus | 4.8mmD, 6.5mmD |
| Implant Direct InterActive | 3.0mmD, 3.4mmD |
| Implant Direct SwishActive | 3.0mmD, 3.4mmD |
| Blue Sky Bio Quattro | Regular Platform (RP) |
The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that guide healing tissue.
Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.
The provided text describes a 510(k) premarket notification for the "Anatotemp Anatomic Dental Implant Healing Abutment." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a clinical study with a specific test set, ground truth, and expert adjudication as one would find for a novel AI/imaging device.
Therefore, many of the requested criteria cannot be directly extracted from this document, as the regulatory pathway for this device (a dental implant healing abutment) does not involve the same type of performance evaluation as, for instance, an AI-powered diagnostic imaging system.
This document primarily relies on non-clinical testing (biocompatibility, chemical characterization, packaging, sterilization, shelf-life, and reverse engineering analysis) and comparison to a predicate device to establish substantial equivalence. It explicitly states that "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device."
Here's an attempt to address your points based on the provided text, highlighting where information is not applicable or not present for this type of device submission:
Acceptance Criteria and Device Performance for the Anatotemp Anatomic Dental Implant Healing Abutment
Since this is a 510(k) submission for a physical medical device (dental implant healing abutment) demonstrating substantial equivalence to a predicate, the "acceptance criteria" and "device performance" are typically related to material properties, biocompatibility, sterility, and functional equivalence, rather than diagnostic accuracy metrics as would be seen for an AI system. The study described is a series of non-clinical tests and a comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards and characteristics required for demonstrating substantial equivalence to the predicate device, as well as the successful completion of the non-clinical tests. Performance is reported as meeting these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility (Abutment - PMMA) | Successful completion of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Maximization Sensitization, Intracutaneous Study), ISO 10993-11 (Systemic Toxicity), ISO 10993-3 (Bacterial Reverse Mutation), ISO 10993-6 (Implantation - 4 wk rabbit, 9 wk rabbit), and ISO 10993-10 (Intracutaneous Study w/ EO Cycle 20).Conclusion: "would not be expected to be toxic, carcinogenic, or cause adverse reactions when in contact with tissue/bone." |
| Material Biocompatibility (Titanium Dental Screw) | Successful completion of ISO 10993-5 (Cytotoxicity).Conclusion: "showed no evidence of causing cell lysis or toxicity." |
| Chemical Characterization (Abutment Material) | Performed according to ISO 10993-18 and USP Physiochemical Tests - Plastics <661>. (Specific results not detailed beyond "performed.") |
| Sterilization Efficacy | Validated per EN ISO 11135:2014 and ISO 11135:2014 (overkill half-cycle approach).Demonstrated ability to be reliably sterilized to a sterility level of 10-6 using Cycle 20 (EXC-1). |
| Packaging Integrity & Sterility Maintenance | Validated per BS EN ISO 11607-1:2009+A1:2014.Distribution simulation study met stated requirements. Accelerated aging (36 months) per ASTM F1980-07 (2011) met stated requirements (visual inspection, dye penetration, peel testing). |
| Longevity/Temporary Use Duration | Tested to support a maximum temporary placement of 180 days (compared to predicate's 90 days). Implied success as it's presented as not affecting substantial equivalence. |
| Compatibility with OEM Implant Systems | Reverse engineering analysis conducted on OEM implant systems. Measurements and statistical analysis performed to identify tolerance limits."Previously described engineering studies will be performed on an annual basis" to ensure ongoing compatibility. |
| Substantial Equivalence to Predicate Device (Contour Healer) | Demonstrated through comparison of intended use, technological characteristics, and performance data, addressing differences in material (PMMA vs. PEEK Classix) and maximum implantation time (180 vs. 90 days) with supporting non-clinical data. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the non-clinical testing, specific sample sizes are not explicitly stated for each test (e.g., number of animals for biocompatibility, number of packages/devices for sterilization/packaging). The document mentions "sample of the OEM implants were measured" for reverse engineering. This is not a "test set" in the context of an AI study.
- Data Provenance: Not applicable for this type of submission. The data is generated from internal company testing and contract lab testing, not patient data from a specific country or collected retrospectively/prospectively in a clinical setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device does not use human "experts" to establish a ground truth for performance evaluation in the way an AI diagnostic imaging system would. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM, USP) and laboratory protocols.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" in the context of human interpretation or diagnostic accuracy for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. The document explicitly states: "Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device..." An MRMC study is a type of clinical study, typically for diagnostic devices or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission type is based on:
- Regulatory Standards: Compliance with ISO, ASTM, and USP standards for biocompatibility, sterility, packaging, etc.
- Engineering Specifications: Data derived from reverse engineering analysis of OEM implant systems to ensure compatibility.
- Predicate Device Equivalence: The characteristics and performance of the legally marketed predicate device (Contour Healer).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Buckeve Medical Technologies LLC Terry Philibin, DDS, MS, MBA President/CEO 405 Niles Cortland Road SE, Suite 202 Warren, Ohio 44484
September 28, 2017
Re: K171922
Trade/Device Name: Anatotemp Anatomic Dental Implant Healing Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 31, 2017 Received: September 1, 2017
Dear Terry Philibin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMANSERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Anatotemp Anatomic Dental Implant Healing Abutment
Indications for Use (Describe)
The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids ir creating an esthetic emergence through the nealing period. The single use, sterlized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.
Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:
| Implant Brand and Type | Implant Platform Size |
|---|---|
| Implant Direct Legacy | 3.5mmD, 4.5mmD, 5.7mmD |
| Implant Direct ReActive | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlus | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlant | 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD |
| Implant Direct SwishPlus | 4.8mmD, 6.5mmD |
| Implant Direct InterActive | 3.0mmD, 3.4mmD |
| Implant Direct SwishActive | 3.0mmD, 3.4mmD |
| Blue Sky Bio Quattro | Regular Platform (RP) |
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 )
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publisting Services (301) 443-6740 EF
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510(k) Summary
Summary of information in accordance with SMDA 1990 and CFR 807.92
SUBMITTER l.
Buckeye Medical Technologies LLC 405 Niles Cortland Rd SE Ste 202 Warren, OH 44484
| Phone: | (330) 719-9868 |
|---|---|
| Contact: | Terry B Philibin DDS, MS, MBA |
| Email: | tphilibin@anatotemp.com |
| Date Prepared: | September 26, 2017 |
DEVICE II.
Device Trade Name:
Device Common Name: Device Classification Name: Regulatory Class: Regulation Number: Product Code:
Anatotemp Anatomic Dental Implant Healing Abutment Anatomic Dental Implant Healing Abutment Endosseous Dental Implant Abutment Class II 21 CFR 872.3630 NHA
PREDICATE DEVICE III.
Predicate:
Contour Healer (K112099)
Reference Predicates:
Legacy Dental Implants (K073033) ReActive Dental Implant System (K080713) RePlus Dental Implants (K073161) Spectra System (K061319) InterActive/ SwishPlus2 Implant System (K130572) InterActive/SwishActive System (K143011) Blue Sky Bio Dental Implant System (K102034)
Section 5
Anatotemp.
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DEVICE DESCRIPTION IV.
The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that quide healing tissue.
Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.
V. INDICATIONS FOR USE
The Anatotemp Anatomic Dental Implant Healing Abutment is a premanufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.
| Implant Brand and Type | Implant Platform Size |
|---|---|
| Implant Direct Legacy | 3.5mmD, 4.5mmD, 5.7mmD |
| Implant Direct ReActive | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlus | 3.5mmD, 4.3mmD, 5.0mmD |
| Implant Direct RePlant | 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD |
| Implant Direct SwishPlus | 4.8mmD, 6.5mmD |
| Implant Direct InterActive | 3.0mmD, 3.4mmD |
| Implant Direct SwishActive | 3.0mmD, 3.4mmD |
| Blue Sky Bio Quattro | Regular Platform (RP) |
Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:
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COMPARISONS OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE
Table 1
| Parameter | Device | Predicate Device | Differences |
|---|---|---|---|
| Device Name | Anatotemp Anatomic Dental ImplantHealing Abutment | Contour Healer | Device Namedifference does notaffect substantialequivalence (SE) |
| Company Name | Buckeye Medical Technologies LLC | Contour Healer LLC | Company Namedifference does notaffect SE |
| 510(k) | K171922 | K112099 | 510(k) # differencedoes not affect SE |
| Class | II | II | Same |
| 21 CFR Number | 872.3630 | 872.3630 | Same |
| Code | NHA | NHA | Same |
| Description | Temporary healing abutment is aplastic component with an anatomiccontour at tissue level and an anti-rotational connection feature thatengages the internal aspects of theendosseous implant and is securedwith a titanium screw. Abutments arestraight versions only. | Abutment is a plasticpost with a predefinedjunction and abutmentcore. The plastic stemof the abutmentengages the internalaspects of theendosseous implantand is secured with aseparate retainingscrew. The abutment ispackaged with astainless steel screw forretaining the temporaryhealing abutment to theendosseous implant.The abutments areprovided in straightversions only. | Descriptions are thesame except for theinclusion of a titaniumscrew with the Deviceand a stainless steelscrew with thePredicate Device. Thismaterial selectiondifference does notaffect SE |
| Use Features | Premanufactured prosthetic dentalimplant healing abutment. Screwretained. | Pre-manufacturedprosthetic component;screw-retained | Same |
| AncillaryComponents | Not applicable. Used temporarily,attached to permanent dental implantduring healing phase. | Not applicable; forattachment toendosseous permanentimplant | Same |
| Intended Use | Temporary dental implant healingabutment used in conjunction withpermanent endosseous dental implantfixture to aid in prostheticrehabilitation. | To be used inconjunction with anendosseous dentalimplant fixture to aid inprosthetic rehabilitation | Same |
| Indications forUse | The Anatotemp Anatomic DentalImplant Healing Abutment is a pre-manufactured healing abutmentintended for use with endosseousroot-form dental implants to aid inprosthetic rehabilitation. The abutmentis a temporary device that aids increating an esthetic emergencethrough the gingiva during the healingperiod. The single use, sterilizeddevice is used by dental professionalsduring the dental implant healingprocess and is removed prior topermanent prosthetic placement.Anatotemp Anatomic Dental ImplantHealing Abutments are compatiblewith the following implant systems:Implant Direct [Legacy] 3.5mmD,4.5mmD, 5.7mmDImplant Direct [ReActive] 3.5mmD,4.3mmD, 5.0mmDImplant Direct [RePlus] 3.5mmD,4.3mmD, 5.0mmDImplant Direct [RePlant] 3.5mmD,4.3mmD, 5.0mmD, 6.0mmDImplant Direct [SwishPlus] 4.8mmD,6.5mmDImplant Direct [InterActive] 3.0mmD,3.4mmDImplant Direct [SwishActive] 3.0mmD,3.4mmDBlue Sky Bio [Quattro] RegularPlatform (RP) | The Contour HealerTemporary Abutment isintended for use with aroot-form endosseousdental abutment to aidin prostheticrehabilitation. Theabutment is aprovisional restorationthat aids in creating anesthetic emergencethrough the gingivaduring the healingperiod. The device isfor use by dentalprofessionals for singlerestorations inadults. The device isfor single-use only andmay not be re-processed.These abutments aredesigned to work withthe following implantsystems:Zimmer [Screw-VentDental Implant System]Nobel Biocare [ReplaceHA Coated Implant,Replace TiUniteEndosseous Implant,Nobel BiocareEndosseous Implants,and Groovy Implants]BioHorizons[BioHorizons TaperedInternal Implant System] | The Indications for Usediffer in compatibleimplants. |
| End User | Implant dentist, Oral Surgeon,Periodontist, Prosthodontist | Dentist, periodontist,oral surgeon | Same |
| Frequency of Use | Single Use | Single Use | Same |
| Method of Use | Temporary dental implant healingabutment: 180 days maximum. | Temporary prosthesis;90 days maximum | 180 days vs. 90 daysmaximum implantationtime. Additional testingwas conducted on theDevice to ensure alonger implantationduration; this does notaffect SE |
| AbutmentMaterial | Polymethylmethacrylate (PMMA) | PEEK Classix;polyetheretherketone | PMMA vs. PEEKClassix. Materials aredifferent, but extensivetesting shows that bothmaterials arebiocompatible; thus,this does not affect SE |
| Abutment Design | Temporary healing abutment withanatomic shapes to mimic tooth shapeat the tissue level and specific toothlocations. Various platform sizesincluded the following: 3.5, 4.5, 5.7,3.5, 4.3, 5.0, 6.0, 4.8, 6.5, 3.0, 3.4,and RP. Straight versions only. | Contoured shaped withinterfaces to matchendosseous implantswith various platformsize [abutment toimplant diameters of5.0, 4.3, 4.5, and5.7mm], in straightversions only | Inclusion of additionalimplant platformdiameters does notaffect SE |
| Implant/AbutmentConnection | Various shaped abutment connectionsused to engage the permanentimplant and provide anti-rotationalstability | Various shapedabutment connectionsused to engage thepermanent implant andprovide anti-rotationalstability | Same |
| Screw Material | 6AL-4V ELI Titanium | Stainless Steel | Titanium vs. StainlessSteel. Testing ofDevice screw showedthat the screw isbiocompatible; thus,this does not affect SE |
| Sterility | Sterilized via ethylene oxide | Non-sterile; intended forautoclave sterilizationby end user | Sterile vs. Non-Sterile.Sterilization of devicedoes not affect SE. |
| Packaging | Sealed Tyvek PETG single unit trays | Round plastic vial withscrew cap | PETG Tray vs. PlasticVial. PETG packagingdoes not affect SE. |
Anatotemp.
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VII. PERFORMANCE DATA
Non-Clinical Testing
Non-clinical testing included biocompatibility testing of the abutment material and titanium abutment screw, chemical characterization of abutment material, biological risk assessment of the abutment material, packaging validation, sterilization validation, shelf-life validation, and reverse engineering analysis of the OEM implant systems.
Chemical testing for the Anatotemp Anatomic Dental Implant Healing Abutment included:
-
ISO 10993-18 . Chemical Characterization
Biocompatibility testing for the Anatotemp Anatomic Dental Implant Healing Abutment included: -
Cytotoxicity Using the ISO Elution Method ISO 10993-5 ●
-
ISO Maximization Sensitization Study ISO 10993-10 ● ISO 10993-10
-
ISO Intracutaneous Study ● ●
- ISO Systemic Toxicity Study ISO 10993-11
-
Bacterial Reverse Mutation Study ● ISO 10993-3
Anatotemp.
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●
- . Implantation (4 wk rabbit)
- ISO 10993-6 ISO 10993-6
- . Implantation (9 wk rabbit)
ISO Intracutaneous Study w/ EO Cycle 20 ISO 10993-10
Biocompatibility testing for the Titanium Dental Screw included:
- . Cytotoxicity Using the ISO Elution Method ISO 10993-5
Chemical characterization testing was performed on the Anatotemp Anatomic Dental Implant Healing Abutment per ISO 10993-18 "Chemical characterization of materials" and United States Pharmacopeia (USP) Physiochemical Tests -Plastics <661>.
A Biological Risk Assessment was generated based upon the results of the biocompatibility tests on the Anatotemp Anatomic Dental Implant Healing Abutment. "Based on the results of the biological and chemical characterization testing, the Anatotemp would not be expected to be toxic, carcinogenic, or cause adverse reactions when in contact with tissue/bone."
Cytotoxicity testing was also performed for the Titanium Dental Screw per ISO 10993-5, and the testing showed that the "test article extract showed no evidence of causing cell lysis or toxicity."
The sterilization validation methodology was based on EN ISO 11135:2014 and ISO 11135:2014 requirements. This protocol details a full sterilization process validation using the overkill half-cycle approach. Successful completion of the validation process demonstrated that the product can be reliably sterilized to a sterility level of 10-6 using the current validated Cycle 20 (EXC-1.)
Packaging validation study was also conducted. According to ATPKG01 Protocol, "the purpose of this validation study is to ensure that the specified packaging will protect the device from damage during the post-sterilization handling and storage while maintaining sterility during the state shelf life," and the validation study is "based on BS EN ISO 11607-1:2009+A1: 2014 standard titled: Packaging for Terminally Sterilized Medical Devices – Part 1, sections 6.3.5, 6.4.2, and 6.4.3." In the ATPKG01: Distribution Simulation Report Executive Summary, it states that "The distribution simulation study has been completed and has met the stated requirements."
Thirty-six-month packaging accelerated aging validation was also conducted in accordance with ATPKG01 Rev. A Protocol, Packaging for Terminally Sterilized Medical Devices: BS EN ISO 11607-1:2009+A1:2014. The Anatotemp Anatomic Dental Implant Healing Abutment packaging met the stated requirements outlined in protocol ATPKG01 for accelerated aging, visual inspection, dye penetration testing, and peel testing. Accelerated aging was performed according to ASTM F1980-07 (2011).
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Reverse engineering analysis testing was conducted on the OEM implant systems with which we claim compatibility. A sample of the OEM implants were measured and analyzed using statistical software to identify tolerance limits for our designs. Additionally, the OEM screws were measured and tested using GO/NO-GO gauges. In order to ensure ongoing implant to proposed device compatibility, the previously described engineering studies will be performed on an annual basis.
Clinical Testing
Formal clinical studies were not conducted to support the claim for substantial equivalence to the predicate device following the recommendations of the Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Dental Implant Abutments issued May 12, 2004.
COMPARISON STATEMENT AND CONCLUSIONS VIII.
The new device and the predicate device are both non-load bearing temporary anatomic dental implant healing abutments. Both are used during the time of dental implant healing and then removed prior to permanent dental implant abutment and crown placement. Both devices exhibit a tooth shape at the tissue level and exhibit an anti-rotational connection feature that inserts into the dental implant. Both devices are secured with an abutment screw. Both devices are positioned well below the occlusal plane and designed to be non-load bearing. Both devices are not used for occlusal function.
The Anatotemp Anatomic Dental Implant Healing Abutment does differ from the predicate device in material composition. The Anatotemp Anatomic Dental Implant Healing Abutment is fabricated from a polymethylmethacrylate plastic as opposed to polyetheretherketone (PEEK Classix). Due to the device being in contact with tissue for greater than 30 days, an exhaustive risk assessment analysis was undertaken including biocompatibility and chemical characterization studies. This analysis concluded that the Anatotemp Anatomic Dental Implant Healing Abutment would not be expected to be toxic, carcinogenic, or cause adverse reactions when in contact with tissue/bone. Cytotoxicity testing on the titanium abutment screw also returned results which determined that the screws showed no evidence of causing cell lysis or toxicity.
The information provided in this submission demonstrates that the Anatotemp Anatomic Dental Implant Healing Abutment is substantially equivalent to the predicate device.
Section 5
Anatotemp.
§ 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.)