(93 days)
No
The device description and intended use clearly define a physical, pre-manufactured healing abutment. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties, sterilization, and compatibility, not algorithmic performance.
Yes
The device is described as a "healing abutment" that "aids in creating an esthetic emergence through the gingiva during the healing period," indicating a direct role in the biological healing process, which is a therapeutic function.
No
The device is a temporary healing abutment used during dental implant recovery to shape the gingiva for prosthetic rehabilitation, not to diagnose a condition.
No
The device is a physical healing abutment made of polymethylmethacrylate and titanium, not software.
Based on the provided information, the Anatotemp Anatomic Dental Implant Healing Abutment is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Anatotemp's Function: The Anatotemp is a physical device that is placed in vivo (within the body) to aid in the healing process after dental implant surgery. It is a temporary component that interacts directly with the patient's tissues (gingiva and bone).
- Intended Use: The intended use clearly states it's for "use with endosseous root-form dental implants to aid in prosthetic rehabilitation" and "a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period." This describes a physical, therapeutic function, not a diagnostic one based on analyzing bodily specimens.
Therefore, the Anatotemp Anatomic Dental Implant Healing Abutment falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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) |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingiva, tissue, bone, tooth
Indicated Patient Age Range
Not Found (The predicate device indicates "adults" but this is not explicitly stated for the subject device.)
Intended User / Care Setting
dental professionals, Implant dentist, Oral Surgeon, Periodontist, Prosthodontist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility testing of the abutment material and titanium abutment screw.
Chemical characterization of abutment material per ISO 10993-18 and USP Physiochemical Tests - Plastics 661.
Biological risk assessment of the abutment material.
Packaging validation per ATPKG01 Protocol, based on BS EN ISO 11607-1:2009+A1:2014.
Sterilization validation per EN ISO 11135:2014 and ISO 11135:2014 using an overkill half-cycle approach.
Shelf-life validation (thirty-six-month packaging accelerated aging validation) in accordance with ATPKG01 Rev. A Protocol and ASTM F1980-07 (2011).
Reverse engineering analysis of OEM implant systems for compatibility; samples measured and analyzed with statistical software to identify tolerance limits. OEM screws measured and tested using GO/NO-GO gauges.
Key results:
Biocompatibility testing: "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 for Titanium Dental Screw: "test article extract showed no evidence of causing cell lysis or toxicity."
Sterilization validation: Product reliably sterilized to a sterility level of 10-6 using Cycle 20 (EXC-1).
Packaging validation: "The distribution simulation study has been completed and has met the stated requirements."
Accelerated aging: "met the stated requirements outlined in protocol ATPKG01 for accelerated aging, visual inspection, dye penetration testing, and peel testing."
Reverse engineering analysis: Used to ensure compatibility. Ongoing annual studies planned.
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."
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.
Contour Healer (K112099)
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.
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)
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
§ 872.3630 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.)
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a symbol of interconnectedness or support.
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.
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 (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
2
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publisting Services (301) 443-6740 EF
Image /page/2/Picture/26 description: The image shows the word "Anatotemp." in a stylized font. There is a curved line above the word. The text is in a light color, possibly white or light gray, against a white background. The dot at the end of the word is slightly larger than the rest of the letters.
3
Image /page/3/Picture/3 description: The image shows the word "Anatotemp" in a simple, sans-serif font. Above the word, there is a purple, wavy line. The word is written in black, and the background is white. The logo is simple and modern.
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.
4
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:
5
COMPARISONS OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE
Table 1
| Parameter | Device | Predicate Device | Differences |
|---|---|---|---|
| Device Name | Anatotemp Anatomic Dental Implant | ||
| Healing Abutment | Contour Healer | Device Name | |
| difference does not | |||
| affect substantial | |||
| equivalence (SE) | |||
| Company Name | Buckeye Medical Technologies LLC | Contour Healer LLC | Company Name |
| difference does not | |||
| affect SE | |||
| 510(k) | K171922 | K112099 | 510(k) # difference |
| does not affect SE | |||
| Class | II | II | Same |
| 21 CFR Number | 872.3630 | 872.3630 | Same |
| Code | NHA | NHA | Same |
| Description | Temporary healing abutment is a | ||
| plastic component with an anatomic | |||
| contour at tissue level and an anti- | |||
| rotational connection feature that | |||
| engages the internal aspects of the | |||
| endosseous implant and is secured | |||
| with a titanium screw. Abutments are | |||
| straight versions only. | Abutment is a plastic | ||
| post with a predefined | |||
| junction and abutment | |||
| core. The plastic stem | |||
| of the abutment | |||
| engages the internal | |||
| aspects of the | |||
| endosseous implant | |||
| and is secured with a | |||
| separate retaining | |||
| screw. The abutment is | |||
| packaged with a | |||
| stainless steel screw for | |||
| retaining the temporary | |||
| healing abutment to the | |||
| endosseous implant. | |||
| The abutments are | |||
| provided in straight | |||
| versions only. | Descriptions are the | ||
| same except for the | |||
| inclusion of a titanium | |||
| screw with the Device | |||
| and a stainless steel | |||
| screw with the | |||
| Predicate Device. This | |||
| material selection | |||
| difference does not | |||
| affect SE | |||
| Use Features | Premanufactured prosthetic dental | ||
| implant healing abutment. Screw | |||
| retained. | Pre-manufactured | ||
| prosthetic component; | |||
| screw-retained | Same | ||
| Ancillary | |||
| Components | Not applicable. Used temporarily, | ||
| attached to permanent dental implant | |||
| during healing phase. | Not applicable; for | ||
| attachment to | |||
| endosseous permanent | |||
| implant | Same | ||
| Intended Use | Temporary dental implant healing | ||
| abutment used in conjunction with | |||
| permanent endosseous dental implant | |||
| fixture to aid in prosthetic | |||
| rehabilitation. | To be used in | ||
| conjunction with an | |||
| endosseous dental | |||
| implant fixture to aid in | |||
| prosthetic rehabilitation | Same | ||
| Indications for | |||
| Use | 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 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 Contour Healer | ||
| Temporary Abutment is | |||
| intended for use with a | |||
| root-form endosseous | |||
| dental abutment to aid | |||
| in prosthetic | |||
| rehabilitation. The | |||
| abutment is a | |||
| provisional restoration | |||
| that aids in creating an | |||
| esthetic emergence | |||
| through the gingiva | |||
| during the healing | |||
| period. The device is | |||
| for use by dental | |||
| professionals for single | |||
| restorations in | |||
| adults. The device is | |||
| for single-use only and | |||
| may not be re- | |||
| processed. | |||
| These abutments are | |||
| designed to work with | |||
| the following implant | |||
| systems: | |||
| Zimmer [Screw-Vent | |||
| Dental Implant System] | |||
| Nobel Biocare [Replace | |||
| HA Coated Implant, | |||
| Replace TiUnite | |||
| Endosseous Implant, | |||
| Nobel Biocare | |||
| Endosseous Implants, | |||
| and Groovy Implants] | |||
| BioHorizons | |||
| [BioHorizons Tapered | |||
| Internal Implant System] | The Indications for Use | ||
| differ in compatible | |||
| implants. | |||
| 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 healing | ||
| abutment: 180 days maximum. | Temporary prosthesis; | ||
| 90 days maximum | 180 days vs. 90 days | ||
| maximum implantation | |||
| time. Additional testing | |||
| was conducted on the | |||
| Device to ensure a | |||
| longer implantation | |||
| duration; this does not | |||
| affect SE | |||
| Abutment | |||
| Material | Polymethylmethacrylate (PMMA) | PEEK Classix; | |
| polyetheretherketone | PMMA vs. PEEK | ||
| Classix. Materials are | |||
| different, but extensive | |||
| testing shows that both | |||
| materials are | |||
| biocompatible; thus, | |||
| this does not affect SE | |||
| Abutment Design | Temporary healing abutment with | ||
| anatomic shapes to mimic tooth shape | |||
| at the tissue level and specific tooth | |||
| locations. Various platform sizes | |||
| included 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 with | ||
| interfaces to match | |||
| endosseous implants | |||
| with various platform | |||
| size [abutment to | |||
| implant diameters of | |||
| 5.0, 4.3, 4.5, and | |||
| 5.7mm], in straight | |||
| versions only | Inclusion of additional | ||
| implant platform | |||
| diameters does not | |||
| affect SE | |||
| Implant/Abutment | |||
| Connection | Various shaped abutment connections | ||
| used to engage the permanent | |||
| implant and provide anti-rotational | |||
| stability | Various shaped | ||
| abutment connections | |||
| used to engage the | |||
| permanent implant and | |||
| provide anti-rotational | |||
| stability | Same | ||
| Screw Material | 6AL-4V ELI Titanium | Stainless Steel | Titanium vs. Stainless |
| Steel. Testing of | |||
| Device screw showed | |||
| that the screw is | |||
| biocompatible; thus, | |||
| this does not affect SE | |||
| Sterility | Sterilized via ethylene oxide | Non-sterile; intended for | |
| autoclave sterilization | |||
| by end user | Sterile vs. Non-Sterile. | ||
| Sterilization of device | |||
| does not affect SE. | |||
| Packaging | Sealed Tyvek PETG single unit trays | Round plastic vial with | |
| screw cap | PETG Tray vs. Plastic | ||
| Vial. PETG packaging | |||
| does not affect SE. |
Anatotemp.
6
7
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.
8
●
- . 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 .
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).
9
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.