K Number

Device Name

A.B. Dental Devices Dental Implants System

Manufacturer

A.B Dental Device Ltd.

Date Cleared

2018-11-23

(183 days)

Product Code

NHA

Regulation Number

872.3630

Intended 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

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162482

Reference Devices

K132125, K112440

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of dental implants and associated components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies listed are standard engineering and biocompatibility tests for physical implants.

Therapeutic

Yes
The device is described as "supporting prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function," which is a therapeutic purpose.

Diagnostic

No.

The device is described as a dental implant system indicated for surgical and restorative applications to provide support for prosthetic devices and restore chewing function. There is no mention of it being used to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly lists numerous physical components (implants, healing caps, abutments, etc.) which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct medical intervention on the patient's body.
Device Description: The description details physical components like implants, abutments, and healing caps, which are all physical devices implanted or attached to the patient.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural support and restoration of function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NHA

Device Description

. 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw, maxillary mandibular arch

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162482

Reference Device(s)

K132125, K112440

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

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.

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

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)

K181381

Device Name

A.B. Dental Devices® Dental Implants System

Indications for Use (Describe)

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

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

Device Description and Technological Characteristics

. 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

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

| | lateral incisors and
maxillary and lateral
incisors. Indicated also for
denture stabilization using
multiple implants.
One stage & One-Piece
2.4 mm diameter implants
for temporary use or long
term use: I6, I6b, permit
immediate splint stability
and long term fixation of
new or existing crown,
bridge and prosthesis.
P14 Angulated Abutment
Adapter is to be used with
implant diameter 4.2mm
and 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 gold
colored anodization	Ti-6Al-4V ELI with gold
colored 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
Allowed
angulation	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

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 gold
colored anodization	Ti-6Al-4V ELI	Ti-6Al-4V ELI with gold
colored 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
Allowed
angulation	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-rotation
Wide	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 color
anodization	Ti-6Al-4V ELI with gold color
anodization	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

| Allowed
angulation | No correction allowed | No correction allowed | No correction
allowed |
|-----------------------|-----------------------|-----------------------|--------------------------|
| 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

angulation
Length, mm	11	11	11
Design	Composed Hex
Abutment	Composed Free Rotating
Abutment	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 color
anodization	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
Allowed
angulation	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
Connection
Method/ Platform	Taper fit+ screw /
P64 platform	Taper fit+ screw /
P16 platform
Allowed angulation	No correction allowed	No correction allowed
Length, mm	10	10

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 |
| Connection
Method/Platform | Standard | Standard | Standard |
| Allowed
angulation | 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

	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 Straight
Adaptor	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 Hex
for Straight Adaptor	Plastic Sleeve for
Adaptor
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.

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 872.3630 Endosseous dental implant abutment.

Andrew I. Steen -S

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

A.B. Dental Devices® Dental Implants System

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K181381 510(k) SUMMARY A.B. DENTAL DEVICES® Dental Implants System

Sponsor:

Contact Person:

Predicate Devices

Indications for Use

Device Description and Technological Characteristics

Technological Characteristics Comparison

1. Healing Caps (P0)

2. Cement Retained, Straight Abutments (P3)

3. Overdenture Ball Attachment Abutments (P5)

4. Composed (UCLA) Abutments

5. A.B. LOC Abutments (P25)

6. P64 Straight Adaptor

7. PK Abutment

Performance Data

Substantial Equivalence

Conclusions

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