(183 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
- . P0-3 narrow platform healing caps, 4 and 7 mm length
- PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
- P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
- P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
- . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
- P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
- P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
- P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
- P9HG-3.75 standard platform, composed abutment, gold alloy
- P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
- . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
- . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
- . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
- P64 plastic and Ti alloy sleeve
- P64 healing cap ●
- PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
- PK plastic sleeve
- . PK healing cap
This document is a 510(k) premarket notification for the A.B. Dental Devices® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in a typical medical device AI context.
The "Performance Data" section lists several types of engineering analysis and biocompatibility/sterilization/fatigue testing, but these are for the physical dental implant system itself, not for an AI/algorithm-based diagnostic or assistive device. There is no mention of a "device performance" in terms of clinical metrics like sensitivity, specificity, accuracy, or an effect size for human readers.
Therefore, for the specific questions asked about acceptance criteria and a study proving device performance (especially questions related to AI/algorithm performance), the provided text does not contain the requested information.
Here's why and what's missing:
-
A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing the new components (healing caps, abutments) to previously cleared predicate devices based on material, diameter, platform, length, design, and sterility. There are no performance metrics or acceptance criteria for a diagnostic/assistive function.
-
Sample size used for the test set and the data provenance: Not applicable as there is no "test set" for an AI algorithm. The performance data mentioned relates to physical testing (e.g., fatigue testing), but not clinical trials or data for an algorithm.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established for an AI algorithm.
-
Adjudication method for the test set: Not applicable.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not for an AI-assisted device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
-
The type of ground truth used: Not applicable.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
In summary, this document is a 510(k) submission for conventional dental implant components, not an AI-powered medical device. As such, it does not contain the information requested about acceptance criteria and studies proving the performance of an AI/algorithm-based device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 23, 2018
A.B Dental Device Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004
Re: K181381
Trade/Device Name: A.B. Dental Devices® Dental Implants System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 25, 2018 Received: October 25, 2018
Dear John J. Smith, M.D., J.D.:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for 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 HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page
510(k) Number (if known)
Device Name
A.B. Dental Devices® Dental Implants System
Indications for Use (Describe)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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:
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FORM FDA 3881 (7/17)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
K181381 510(k) SUMMARY A.B. DENTAL DEVICES® Dental Implants System
Sponsor:
A.B. Dental Devices Ltd. 19 Hayalomim St., Ashdod 7761117 Israel
Contact Person:
Gabi Krauss RA Manager Phone: 972-8-8531388 Facsimile: 972-8-8522562 Email: gabi@ab-dent.com
Date Prepared: November 23, 2018
| Name of Device: | A.B. Dental Devices® Dental Implants System |
|---|---|
| Common or Usual Name: | Abutment, implant, dental, endosseous |
| Classification Name: | Endosseous dental implant abutment; 21 CFR §872.3630. |
| Product Code: | NHA |
Predicate Devices
K162482 A.B. DENTAL DEVICES® Dental Implants System (primary) K132125 A.B. DENTAL DEVICES® Dental Implants System (reference) K112440, DENTAL DEVICES® Dental Implants System (reference)
Indications for Use
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description and Technological Characteristics
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
- . P0-3 narrow platform healing caps, 4 and 7 mm length
- PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
{4}------------------------------------------------
- P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
- P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
- . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
- P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
- P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
- P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
- P9HG-3.75 standard platform, composed abutment, gold alloy
- P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
- . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
- . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
- . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
- P64 plastic and Ti alloy sleeve
- P64 healing cap ●
- PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
- PK plastic sleeve
- . PK healing cap
Technological Characteristics Comparison
The purpose of this 510(k) is to expand the current product line to include two new abutments listed above. No substantive changes are being made to the indications as compared to the most recent clearance, and the indications are provided below. Aside for K112440, the indications differ only in respect to indications related to the specific components contained within each submission. K112440 has the same intended use as it allows for implantation in the same anatomic location and, when appropriate, for immediate loading. Comparison tables for each modification are provided below.
| K181381 | K162482 | K132125 | K112440 |
|---|---|---|---|
| A.B. DENTAL DEVICES® | A.B. DENTAL DEVICES® | A.B. DENTAL DEVICES® | The AB Dental Devices |
| Dental Implants System is | Dental Implants System is | Dental Implants System is | implants are intended for |
| indicated for use in | indicated for use in | indicated for use in | surgical' placement in the |
| surgical and restorative | surgical and restorative | surgical and restorative | maxillary mandibular arch |
| applications for placement | applications for placement | applications for placement | to support crowns, bridges, |
| in the bone of the upper or | in the bone of the upper or | in the bone of the upper or | or overdentures in |
| lower jaw to provide | lower jaw to provide | lower jaw to provide | edentulous or partially |
| support for prosthetic | support for prosthetic | support for prosthetic | and/or edentulous patients. |
| devices, such as artificial | devices, such as artificial | devices, such as artificial | I7 Integral implant, I5 |
| teeth, in order to restore | teeth, in order to restore | teeth, in order to restore | Conical implant, P12-T,L |
| the patient's chewing | the patient's chewing | the patient's chewing | Temporary flat connection |
| function. A.B. DENTAL | function. A.B. DENTAL | function. A.B. DENTAL | abutment, connection |
| DEVICES® Dental | DEVICES® Dental | DEVICES® Dental | abutment, and P16 |
| Implants System is | Implants System is | Implants System is | Straight adaptor are |
| indicated also for | indicated also for | indicated also for | appropriate for immediate |
| immediate loading when | immediate loading when | immediate loading when | loading when good primary |
| good primary stability is | good primary stability is | good primary stability is | stability is achieved and |
| achieved and with | achieved and with | achieved and with | with appropriate occlusal |
| appropriate occlusal | appropriate occlusal | appropriate occlusal | loading. |
| loading. | loading. | loading. | |
| Two Stage Implants: I22, | Two Stage Implants: | ||
| I5, I55, I10. | I2,I5,I6BI. | ||
| One Stage: I6, I6b, I6B. | |||
| P4 and P14 angled | One Stage & One-Piece | ||
| abutments are to be used | 3.0 mm diameter implants: | ||
| only with standard platform | I6, I6B, I6BI, are intended | ||
| implants 3.5 mm in | for placement at the | ||
| diameter or larger. | mandibular central and |
{5}------------------------------------------------
| lateral incisors andmaxillary and lateralincisors. Indicated also fordenture stabilization usingmultiple implants.One stage & One-Piece2.4 mm diameter implantsfor temporary use or longterm use: I6, I6b, permitimmediate splint stabilityand long term fixation ofnew or existing crown,bridge and prosthesis.P14 Angulated AbutmentAdapter is to be used withimplant diameter 4.2mmand higher. | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
1. Healing Caps (P0)
| Subject P0-3,(4,7) | Predicate P0-3 | Predicate P0-3.75 | |
|---|---|---|---|
| K-number | K181381 | K132125 | K132125 |
| Material | Ti-6Al-4V ELI with goldcolored anodization | Ti-6Al-4V ELI with goldcolored anodization | Ti-6Al-4V ELI |
| Diameter, mm | 4.0 | 4.0 | 4.5 |
| Platform | Narrow | Narrow | Standard |
| Length, mm | 4, 7 | 2, 3, 5, 6 | 0.5 - 7 |
| Design | Standard | Standard | Standard |
| Allowedangulation | No correction allowed | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Subject P0N-3.75,(4,7) | Predicate P0N-3.75 | Predicate P0-3.75 | |
|---|---|---|---|
| K-number | K181381 | K132125 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Diameter, mm | 3.75 | 3.75 | 4.5 |
| Platform | Standard | Standard | Standard |
| Length, mm | 4, 7 | 3, 5, 6 | 0.5 - 7 |
| Design | Standard | Standard | Standard |
| Allowed angulation | No correction allowed | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
2. Cement Retained, Straight Abutments (P3)
| Subject P3-5,5 | Predicate P3-5,(7,9) | |
|---|---|---|
| K-number | K181381 | K162482 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Diameter, mm | 5.0 | 5.0 |
| Platform | Standard | Standard |
| Length, mm | 5 | 7, 9 |
| Design | Anti -rotation | Anti-rotation |
| Allowed angulation | No correction allowed | No correction allowed |
{6}------------------------------------------------
| Sterility | Non-Sterile | Non-Sterile |
|---|---|---|
| ----------- | ------------- | ------------- |
| Subject P3S-3 | Predicate P3S-3.75 | Predicate P3-3 | |
|---|---|---|---|
| K-number | K181381 | K112440 | K112440 |
| Material | Ti-6Al-4V ELI with goldcolored anodization | Ti-6Al-4V ELI | Ti-6Al-4V ELI with goldcolored anodization |
| Diameter | 4.5 | 4.5 | 4.5 |
| Platform | Narrow | Standard | Narrow |
| Shoulder Height | 1, 2, 3 | 1, 2, 3 | |
| Design | Anatomic Anti-rotation | Anatomic Anti-rotation | Anti-rotation |
| Allowedangulation | No correction allowed | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Subject P3S-Peek-3 | Predicate P3S-Peek-3.75 | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | PEEK | PEEK |
| Diameter | 4.5 | 4.5 |
| Platform | Narrow | Standard |
| Shoulder Height | 1, 2, 3 | 1, 2, 3 |
| Design | Anatomic Anti -rotation | Anatomic Anti -rotation |
| Allowed angulation | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P3SW-3.75 | Predicate P3S-3.75 | Predicate P3W-3.75 | |
|---|---|---|---|
| K-number | K181381 | K112440 | K112440 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Diameter | 5.5 | 3.75 | 5.5 |
| Platform | Standard | Standard | Standard |
| Shoulder Height | 1, 2, 3 | 1, 2, 3 | 1, 2, 3 |
| Design | Anatomic Anti-rotationWide | Anatomic, Anti-rotation | Anti-rotation |
| Allowed angulation | No correction allowed | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Subject P3W-3 | Predicate P3-3 | Predicate P3W-3.75 | |
|---|---|---|---|
| K-number | K181381 | K112440 | K112440 |
| Material | Ti-6Al-4V ELI with gold coloranodization | Ti-6Al-4V ELI with gold coloranodization | Ti-6Al-4V ELI |
| Diameter | 5.5 | 3.75 | 5.5 |
| Platform | Narrow | Narrow | Standard |
| Length | 9 | 9, 12 | 9, 12 |
| Design | Anti-rotation | Anti-rotation | Anti-rotation |
{7}------------------------------------------------
| Allowedangulation | No correction allowed | No correction allowed | No correctionallowed |
|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
3. Overdenture Ball Attachment Abutments (P5)
| Subject P5-3,(4,5,6) | Predicate P5-3,(1,2,3) | Predicate P5-3.75 | |
|---|---|---|---|
| K-number | K181381 | K132125 | K132125 |
| Material | Ti-6Al-4V ELI with gold color anodization | Ti-6Al-4V ELI with gold color anodization | Ti-6Al-4V ELI |
| Platform | Narrow | Narrow | Standard |
| Length, mm | 4, 5, 6 | 1, 2, 3 | 1, 2, 3, 4, 5, 6 |
| Design | Ball Attachment | Ball Attachment | Ball Attachment |
| Allowed angulation | No correction allowed | No correction allowed | No correction allowed |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Subject P5-3.75,20-(4,6) | Predicate P5-3.75,20-(1,2,3,5) | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform | Standard | Standard |
| Length, mm | 4, 6 | 1, 2, 3, 5 |
| Angle, ° | 20 | 20 |
| Design | Ball Attachment | Ball Attachment |
| Sterility | Non-Sterile | Non-Sterile |
4. Composed (UCLA) Abutments
| Subject P9R-3.75,11, P9HR-3.75,11 | Predicate P9-3.75,11, P9H-3.75,11 | ||
|---|---|---|---|
| K-number | K181381 | K132125 | |
| Material | FWM 1058 Cobalt Chrome Alloy per ASTM F1058 | Ti-6Al-4V ELI | |
| Connection Method/Platform | Standard | Standard | |
| Diameter, mm | 3.75 | 3.75 | |
| Allowed angulation | No correction allowed | No correction allowed | |
| Length, mm | 11 | 11 | |
| Design | Composed Abutment | Composed Abutment | |
| Sterility | Non-Sterile | Non-Sterile | |
| Subject P9HG-3.75,11 | Predicate P9G-3.75,11 | Predicate P9H-3.75,11 | |
| K-number | K181381 | K132125 | K132125 |
| Material | Gold Alloy 6019 | Gold Alloy 6019 | Ti-6Al-4V |
| \Platform | Standard | Standard | Standard |
| Diameter, mm | 3.75 | 3.75 | 3.75 |
| Allowed | No correction allowed | No correction allowed | No correction allowed |
{8}------------------------------------------------
| angulation | |||
|---|---|---|---|
| Length, mm | 11 | 11 | 11 |
| Design | Composed HexAbutment | Composed Free RotatingAbutment | Composed Hex Abutment |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
5. A.B. LOC Abutments (P25)
| Subject P25-3.75,(0,1,2) | Predicate P25-3.75,(3,4,5,6,7) | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform | Standard | Standard |
| Diameter, mm | 3.75 | 3.75 |
| Allowed angulation | No correction allowed | No correction allowed |
| Length, mm | 0, 1, 2 | 3, 4, 5, 6, 7 |
| Design | Integrated screw, attachment | Integrated screw, attachment |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P25-3 | Predicate P25-3.75 | |
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI with gold coloranodization | Ti-6Al-4V ELI |
| Platform | Narrow | Standard |
| Diameter, mm | 3 | 3.75 |
| Allowed angulation | No correction allowed | No correction allowed |
| Length, mm | 0, 1, 2, 3, 4, 5 | 3,4,5,6,7 |
| Design | Integrated screw, attachment | Integrated screw, attachment |
| Sterility | Non-Sterile | Non-Sterile |
6. P64 Straight Adaptor
| Subject P64-3.75 | Predicate P16-3.75 | |
|---|---|---|
| K-number | K181381 | K112440 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform | Standard | Standard |
| Allowedangulation | No correction allowed | No correction allowed |
| Height | 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5 |
| Design | Integrated screw, screw retained | Integrated screw, screw retained |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P64b | Predicate P14b | |
|---|---|---|
| K-number | K181381 | K112440 |
| Material | Delrin | Delrin |
| ConnectionMethod/ Platform | Taper fit+ screw /P64 platform | Taper fit+ screw /P16 platform |
| Allowed angulation | No correction allowed | No correction allowed |
| Length, mm | 10 | 10 |
{9}------------------------------------------------
| Design | Plastic Sleeve for Adaptor | Plastic Sleeve for Adaptor |
|---|---|---|
| Sterility | Non-Sterile | Non-Sterile |
| Subject P64-bT | Predicate P14-bT | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Connection | Taper fit+ screw / | Taper fit+ screw / |
| Method/ Platform | P64 platform | P16 platform |
| Allowed anqulation | No correction allowed | No correction allowed |
| Length, mm | 12 | 12 |
| Design | Titanium Sleeve for Adaptor | Titanium Sleeve for Adaptor |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P0-P64,5 | Predicate P0-P14 | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Connection | P64 | P14/P16 |
| Method/Platform | ||
| Allowed angulation | No correction allowed | No correction allowed |
| Height | 5 | 2.5, 4, 5, 7 |
| Design | Temporary healing cap | Temporary healing cap |
| Sterility | Non-Sterile | Non-Sterile |
7. PK Abutment
| Subject PK-P3-3.75 | Predicate P3-3.75 | Predicate P3S-3.75,(1,2,3) | |
|---|---|---|---|
| K-number | K181381 | K112440 | K112440 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| ConnectionMethod/Platform | Standard | Standard | Standard |
| Allowedangulation | No correction allowed | No correction allowed | No correction allowed |
| Height/Length,mm | 1, 2, 3, 4 | 5, 7, 9 | 1, 2, 3 |
| Design | Anti-Rotation Abutment | Anti Rotation Abutment | Anatomic Anti-Rotation Abutment |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Subject PK-P0-3.75 | Predicate P0-P14 | |
|---|---|---|
| K-number | K181381 | K132125 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Connection | PK | P14/P16 |
| Method/Platform | ||
| Allowed angulation | No correction allowed | No correction allowed |
| Height | N/A | 2.5, 4, 5, 7 |
| Design | Temporary healing cap | Temporary healing cap |
| Sterility | Non-Sterile | Non-Sterile |
{10}------------------------------------------------
| Subject PK-P2-3.75 | Predicate P14b | |
|---|---|---|
| K-number | K181381 | K112440 |
| Material | Delrin | Delrin |
| Connection | Taper fit/ | Taper fit+ screw / |
| Method/ Platform | PK platform | P16 platform |
| Allowed angulation | No correction allowed | No correction allowed |
| Length, mm | 10 | 10 |
| Design | Plastic Sleeve for StraightAdaptor | Plastic Sleeve for Adaptor |
| Sterility | Non-Sterile | Non-Sterile |
| Subject PK-P2H-3.75 | Predicate P14b | |
|---|---|---|
| K-number | K181381 | K112440 |
| Material | Delrin | Delrin |
| Connection Method/Platform | Taper fit/PK platform | Taper fit+ screw /P16 platform |
| Allowed angulation | No correction allowed | No correction allowed |
| Length, mm | 10 | 10 |
| Design | Plastic Sleeve with Hexfor Straight Adaptor | Plastic Sleeve forAdaptor |
| Sterility | Non-Sterile | Non-Sterile |
Performance Data
- Engineering analysis to determine if additional components constitute a new worst-case. ●
- . Biocompatibility testing per ISO 10993-1 per ISO 10993 as originally presented in K162482
- Cytotoxicity testing per ISO 10993-5 .
- Sterilization validation as per ANSI/AAMI/ISO 17665-1: 2006 as originally presented in . K162482
- Fatigue testing as per ISO 14801 as originally presented in K162482 ●
Substantial Equivalence
The A.B. Dental Devices® Dental Implants System has the same indications and similar technological characteristics and principles of operation as its predicate device. Performance data demonstrate that the A.B. Dental Devices® Dental Implants System is substantially equivalent.
Conclusions
The A.B. Dental Devices® Dental Implants System is substantially equivalent to the predicate device.
§ 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.)