K Number

Device Name

PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT

Manufacturer

PALTOP ADVANCED DENTAL SOLUTIONS LTD

Date Cleared

2013-08-27

(186 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching. The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided. The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

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

K112795, K092555, K080396

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and its intended use, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes.
This device is designed to be surgically implanted to support prosthetic devices, such as artificial teeth, to restore chewing function, indicating it has a therapeutic purpose.

Diagnostic

The device is an implant used to support prosthetic devices and restore chewing function, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical implant fabricated from titanium alloy, which is a hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The description clearly states that the Paltop Narrow Implant is a "substitute for a natural tooth" and an "endosseous screw type implant." It is a physical device implanted into the bone.
Intended Use: The intended use is for surgical and restorative applications to provide support for prosthetic devices and restore chewing function. This is a mechanical and structural function, not a diagnostic test performed on a sample.

The device is a medical device, specifically a dental implant, but it does not fit the definition of an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided.

The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws

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)

Non Clinical Tests:
Risk analysis process was conducted to assess the impact of the modification of the device. Bench testing, verification and validation activities previously conducted to the standard device were re-evaluated for their applicability to the modified device. Fatigue testing of the modified device showed that implants are safe and effective and meets existing acceptance criteria. Other performance testing and validations (corrosion resistance, surface analysis, biocompatibility evaluation, sterilization and shelf life validation) previously conducted to the standard device were shown to be applicable to the modified design, as their results may not be affected by the dimensional changes.
Bench testing and validations demonstrates that the narrow implants are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness.

Clinical Tests:
Not applicable

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.

K112795, K092555, K080396

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.

Not Found

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

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a bold, modern font. Below the company name and logo is the tagline "With you to the TOP" in a cursive font.

510(k) SUMMARY

510(k) Number K | 3046 2

Applicants Name: Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 4 6271711 F +972 4 6275363

Contact Person: Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 5 23 520050 F +972 4 6275363 Email: tal@paltopdental.com

AUG 27 2013

February 18th, 2013 Date Prepared:
Trade Name: Paltop Narrow Implant

Classification Name: Implant, Endosseous, Root-form

Common usual name: Dental Implant

Medical Specialty: Dental

Product Code: DZE, NHA

Device Class: Class II
Regulation Number: 872.3640
Review Panel: Dental Device Panel

Predicate Devices:

Paltop Narrow Implant is relying on the combination of the following predicate devices:

Image /page/1/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left, followed by the word "PALTOP" in a bold, sans-serif font. A small circle with a degree symbol is located to the right of the "P". The text "With you to the TOP" is written in a cursive font below the logo.

Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared . under K112795; product code DZE, NHA (Implant, Endosseous, Root-Form).
UNO Narrow Implant (MIS Implant Technologies Ltd.) cleared under K092555; . product code DZE, NHA (Implant, Endosseous, Root-Form).
Osseospeed " Narrow (ASTRA Tech AB) cleared under K080396; product code . DZE,NHA (Implant, Endosseous, Root-Form)

Intended Use / Indication for Use:

Device Description:

The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is

Image /page/2/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a modern, sans-serif font. Below the company name is the tagline "With you to the TOP" in a cursive font.

limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided.

The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

Substantial Equivalence:

The proposed Paltop Narrow Implants have similar indications for use, technological characteristics, mode of operation and performance specification as the predicates MIS Implants and Astra-Tech Implants. The proposed devices have the same intended use as the predicates and are placed using the same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.

	PALTOP Narrow	PALTOP Dental	MIS UNO Narrow	Astra Tech
	lmplants	Implant System	lmplant	OsseoSpeed Narrow
K#		Cleared under	Cleared under	Cleared under
		K#112795	KHO92555	K#080396
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Manufacturer	Paltop Advanced	Paltop Advanced	MIS Implant	Astra Tech AB
	Dental Solutions Ltd.	Dental Solutions Ltd.	Technologies Ltd.
Intended Use/	The Narrow Implant is	The Paltop Dental	The UNO Narrow	The OsseoSpeed
Indications for	indicated for use in	lmplant System is	implant is indicated	Narrow is intended to
Use	surgical and	indicated for use in	for use in surgical and	be used to replace
	restorative	surgical and	restorative	missing masticatory
	applications for	restorative	applications for	functional units
	placement in the	applications for	placement in the	(teeth) in single or
	mandibular central,	placement in the	mandibular central,	multiple unit
	lateral incisor and	bone of the upper or	lateral incisor and	applications within
	maxillary lateral	lower jaw to provide	maxillary lateral	the mandible or
	incisor regions of	support for prosthetic	incisor regions of	maxilla. The device
	partially edentulous	devices, such as	partially edentulous	may be equally well in
	jaws where the	artificial teeth, in	jaws where the	single-stage or two-
	horizontal space is	order to restore the	horizontal space is	stage surgical
	limited by the	patient's chewing	limited by the	procedure. It is
	adjacent teeth and	function. The Paltop	adjacent teeth and	indicated for
	PALTOP Narrow	PALTOP Dental	MIS UNO Narrow	Astra Tech
	Implants	Implant System	Implant	OsseoSpeed Narrow
	roots, to provide	Dental Implant
System is indicated
also for immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading.	roots,
jaw to provide
support for prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's chewing
function. Mandibular
central and lateral
incisors must be
splinted if using two
or more φ3.0mm
implnats adjacent to
one another. . The
UNO Narrow Implant
is indicated for
immediate
implantation in the
extraction sites or
implantation in
partially healed or
completely healed
alveolar ridge
situations.
When a one stage
surgical procedure is
applied, the implant
may be immediately
loaded when good
primary stability is
achived and the
occlusal load is
appropriate.	immediate
implantation in
extraction sites or
implantation in
partially healed
alveolar ridge
situations. When a
one-stage surgical
approach is applied,
the implant may be
immediattely loaded
when good primary
stability is achived
and functional load is
appropriate. The
OsseoSpeed Narrow
product line shall be
used only to replace
maxillary lateral
incisors and
mandibular lateral
and central incisors.
The fluoride-modified
surface, though
having a fluoride ion
level far below the
needed for caries
prevention in theeth,
provides a favorable
substrate for bone
attachment and
osseointegration.
OsseoSpeed Narrow
is especially indicated
for use in soft bone
applications where
implants with other
implant surface
treatment may be
less effective.Because
initial stability may be
difficult to obtain in
Type IV bone,
immediate loading of
sungle tooth
restorations may not
be appropriate in
such situations.
Components	Dental implants,
cover screws healing
caps; abutment
systems and
superstructures;	Dental implants,
cover screws healing
caps; abutment
systems and
superstructures;
surgical instruments.	Dental implants,
cover screws healing
caps; abutment
systems and
superstructures;	Dental implants,
cover screws healing
caps; abutment
systems and
superstructures;
Clinical Data	Not applicable	Not applicable	Not applicable	Not applicable
	PALTOP Narrow
Implants	PALTOP Dental
Implant System	MIS UNO Narrow
Implant	Astra Tech
OsseoSpeed Narrow
Supplied
Sterile	Yes	Yes	Yes	Yes
Re-Use	No	No	No	No
Material
Composition	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy
Surface
treatment	Sand Blasting and
Acid Etching	Sand Blasting and
Acid Etching	Sand Blasting and
Acid Etching	Fluride-modified
surface
Shape	Screw type	Screw type	Screw type	Screw type
Length	10mm, 11.5mm,
13mm, 16mm	8mm, 10mm,
11.5mm, 13mm,
16mm	10mm, 11.5mm,
13mm, 16mm	11mm, 13mm, 15mm
Diameters	3.25mm	3.75mm, 4.2mm,
5.0mm	3.0mm	3.0mm
Abutments	Straight and up to 20°	Straight and up to 25°	Straight and up to 20°	Straight and up to 20°
Material
Composition of
Abutments	Titanium alloy,	Titanium alloy, Plastic
(PEEK)	Titanium alloy, Plastic	Titanium alloy
Surface
Treatment of
Abutments	None	None	None	None

Technological Characteristics – comparative table – Narrow Implants

Image /page/3/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo includes a stylized image of a tooth inside of a circle. Next to the image is the company name and the word "PALTOP" in a stylized font.

With you to the TOP

ー

Image /page/4/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left. To the right of the tooth is the word "PALTOP" in a stylized font.

With you to the TOP

The Paltop Narrow Implants have the following similarities to their predicate devices:

Have the same intended use .
Use the same operating principle .
. Incorporate the same basic design
. Incorporate the same materials
. Have similar packaging
Sterilized using the same procedures .

Non Clinical Tests:

Risk analysis process was conducted to assess the impact of the modification of the device. Bench testing, verification and validation activities previously conducted to the standard device were re-evaluated for their applicability to the modified device. Fatigue testing of the modified device showed that implants are safe and effective and meets existing acceptance criteria. Other performance testing and validations (corrosion resistance, surface analysis, biocompatibility evaluation, sterilization and shelf life validation) previously conducted to the standard device were shown to be applicable to the modified design, as their results may not be affected by the dimensional changes.

Image /page/5/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo includes a stylized tooth inside of a circle on the left. To the right of the tooth is the company name, "PALTOP" in large, bold letters. Below the company name is the slogan "With you to the TOP".

Bench testing and validations demonstrates that the narrow implants are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness.

Clinical Tests:

Not applicable

Summary:

The evaluation of Paltop Narrow Implants do not raise any additional concerns regarding safety and effectiveness of the device and therefore Paltop Advanced Dental Solutions Ltd. believes that Paltop Narrow Implants may be considered as substantially equivalent to their predicate devices.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 27, 2013

Paltop Advanced Dental Solutions Limited C/O Mr. Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Hashita 5, PO Box 3568 Caesarea 30889 ISRAEL

Re: K130462

Trade/Device Name: Paltop Narrow Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 25, 2013 Received: July 31, 2013

Dear Mr. Hammer-Topaz:

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.

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Image /page/7/Picture/5 description: The image shows the name "Mary S. Runner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are uniformly sized and spaced, creating a clean and legible presentation.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/8/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo includes a stylized image of a tooth inside of a circle. Next to the circle is the word "PALTOP" in a bold, sans-serif font. Below the logo is the phrase "With you to the TOP" in a cursive font, and below that is the phrase "Indications for Use" in a bold, sans-serif font.

510(k) Number: K130462

Device Name:

PALTOP Narrow Implant

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2013.08.27 16:47:17 -04'00

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510(k) Number: