K Number
K112795
Device Name
PALTOP DENTAL IMPLANT SYSTEM
Date Cleared
2012-04-20

(207 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paltop Dental Implant 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. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments. The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136. "Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. "Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.
More Information

Not Found

No
The device description focuses on the physical characteristics and materials of dental implants and associated components. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies are based on non-clinical tests and a literature review, not on the evaluation of an AI/ML model.

Yes.
The device is used to restore a patient's chewing function by providing support for prosthetic devices (artificial teeth), which directly addresses a health problem (loss of chewing function).

No

The device description indicates that the Paltop Dental Implant System is used for surgical and restorative applications to provide support for prosthetic devices, not to diagnose a condition.

No

The device description clearly outlines physical components made of Ti 6Al 4V ELI, including implants, cover screws, healing caps, abutment systems, and surgical instruments. This indicates a hardware-based medical device, not a software-only one.

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 intervention on the patient's body.
  • Device Description: The description details a physical implant made of titanium, along with associated components like abutments and surgical instruments. These are all physical devices used in a surgical procedure.
  • Anatomical Site: The device is placed in the bone of the upper or lower jaw.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.

The Paltop Dental Implant System is a medical device used for surgical implantation.

N/A

Intended Use / Indications for Use

The Paltop Advanced Dental Solutions Implant 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. The Paltop Dental Advanced Dental Implant Solutions System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Product codes

DZE, NHA

Device Description

Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments.

The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136.

"Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm (as detailed in Table 2: System Components). The implants are suitable for both one and two stage implant procedures.

"Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm (as detailed in Table 2: System Components). The implants are suitable for both one and two stage implant procedures.

The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant.

A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw

Indicated Patient Age Range

Adult and young patients

Intended User / Care Setting

Dental Clinic Setting

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:
A series of safety and performance testing were performed to demonstrate that the Paltop Advanced Dental Solutions Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance, surface analysis and biocompatibility.

Clinical Tests:
A clinical evaluation has been performed based on a literature review.
From current knowledge this literature evaluation of the Paltop Dental Implant System provides sufficient evidence:

  • The presented studies demonstrate that titanium-based dental implants can be installed safely in human patients with a very high overall success rate.
  • The present studies demonstrate compliance of the device in question with the essential requirements (in particular regarding safety and performance) under normal conditions of use.
  • That the device performs as intended by the manufacturer;
  • That the device does not pose any undue safety concerns to either the recipient or end-user.
  • That any risks associated with the use of the device are acceptable when weighed against the benefits to the patient.

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

Not Found

Predicate Device(s)

K063364, K040807, K080156, K091239, K071803, K071370

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside of a circle on the left. To the right of the tooth is the company name, "Advanced Dental Solutions Ltd." in a small, sans-serif font. Below the company name is the word "PALTOP" in a larger, stylized font.

With you to the TOT

APR 2 0 2012

510(k) Number K_1 With you to the TOP | | | | | 4Vanadium ELI (Extra Low
Interstitial) Alloy for
Surgical Implant
Applications. | UL 544 (1998):, Standard for Medical and
Dental Equipment - Ed. 4.0. | | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | anticoagulation
drugs/hemorrhagic
diatheses, bruxism,
parafunctional habits,
unfavorable anatomic bone
conditions, tobacco abuse,
uncontrolled periodontitis,
temporomandibular joint
disorders, treatable
pathologic diseases of the
jaw and changes in the oral
mucosa, pregnancy,
inadequate oral hygiene | and therefore precludes surgical
procedures. Relative contraindications:
Previously irradiated bone, treatment
with anticoagulant drugs or
bisphosphonates, bruxism,
parafunctional habits, untreated and/or
uncontrolled periodontal disease,
temporomandibular joint disease, varous
pathologies of the oral mucosa. | processed in the implantation site. The
folloiwng outline lists the
contraindications:
Debilitating or uncontrolled disease;
pregnance, hemophilia;
granulocytopenia or other bleeding
problems, steroid use, prophylactic
antibiotics, britlle diabetes, Ehler-Danlos
syndrome; osteoradionecrosis, renal
failure, organ transplanation
anticoagulation therapy; unexplained
hypersensitivity, fibrous dysplasis,
regional enteritis. | | 5. ASTM F899 Standard
Specification for Wrought
Stainless Steels for Surgical
Instruments. | | | | |
| User
Population | Adult and young patients
who have been screened to
ascertain that there is
sufficient alveolar bone
width to support the
implant. In general anyone
healthy enough to undergo
routine tooth extraction or
oral surgery is probably
able to receive an implant. | Adult and young patients who have been
screened to ascertain that there is
sufficient alveolar bone width to support
the implant. In general anyone healthy
enough to undergo routine tooth
extraction or oral surgery is probably
able to receive an implant. | Adult and young patients who have been
screened to ascertain that there is
sufficient alveolar bone width to support
the implant. In general anyone healthy
enough to undergo routine tooth
extraction or oral surgery is probably
able to receive an implant. | | 6. ASTM F746-04
(Reapproved 2009)
Standard Test Method for
Pitting or Crevice Corrosion
of Metallic Surgical Implant
Materials. | | | | |
| Components | The Paltop Advanced
Dental Solutions Implant
System consists of one and
two stage endosseous form
dental implants, internal
hexagonal connection;
cover screws and healing
caps; abutment systems
and superstructures;
surgical instruments. | The Alpha-Bio Dental Implant System®
consists of one and two stage
endosseous form dental implants,
internal and external hexagonal; internal
octagonal hexagonal; one piece implants
system; cover screws and healing caps;
abutment systems and superstructures;
surgical instruments. | The MIS Dental Implant System consists
of one and two stage implants, internal
and external hexagonal; cover screw and
healing caps; abutment systems and
suprastructures; surgical instruments. | | 7. ISO 10993-1:2003
Biological evaluation of
medical devices - Part 1:
Evaluation and testing. | | | | |
| Accessories | Surgical Instruments | Surgical Instruments | Surgical Instruments | | 8. ISO 14971:2007 - Risk
Analysis for Medical Device. | | | | |
| Intended
Use
Environment | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | | 9. ISO 9001:2008 - Quality
management systems
requirements. | | | | |
| Clinical
Data | N/A | No information was provided in the 510K
notice. | No information was provided in the 510K
notice. | | 10. ISO 13485:2003
(including CMDCAS Medical
Device Regulations) -
Quality systems medical
devices. | | | | |
| Standards with
which the
Device
Complies | Specification for Wrought Titanium-6Aluminum- | 1. FDA Guidance - Class II
Special Controls Guidance
Document: Root-form
Endosseous Dental
Implants and Endosseous
Dental Implant Abutments.
2. ISO 14801:2007
"Dentistry-Implants-
Dynamic fatigue test for
endosseous dental
implants".
3. ISO 5832-3:1996
Implants for surgery
Metallic materials Part 3:
Wrought titanium 6-
aluminium 4-vanadium
alloy.
4. ASTM F136 Standard | autoclaving, corrosion and thermal exposure. | ISO 7405:1997, Dentistry- Preclinical
Evaluation of Biocompatibility of Medical
Devices Used in Dentistry - Test Methods
for Dental
F136-02a: 2004 Standard Specification
for Wrought
Titanium-6Alumninum-4Vanadium ELI
(Extra Low
Interstitial) Alloy for Surgical Implant
Applications (UNS
R56401).
ASTM F1350-02, 2002 Standard
Specification for Wrought 18 Chromium-
14Nickel-2.5 Molybdenum Stainless Steel
Surgical Fixation Wire (UNS S31673). ISO
13402:1995, Surgical and dental hand
instruments --
Determination of resistance against
autoclaving corrosion and thermal | ASTM F67-95
ISO 9001:2000
ISO 13485:2003 | | 11. ISO 11137:2006
Sterilization of health care
products - Radiation -- Part
1: Requirements for
development, validation
and routine control of a
sterilization process for
medical devices. | | |
| | 12. ISO 11607: Packaging
for terminally sterilized
medical devices -- Part 1:
Requirements for materials,
sterile barrier systems and
packaging systems. | | | | | | | | |
| | 13. ISO 15223:2000:
Medical Devices - Symbols
to be used with medical
device labels, labeling and
Information to be supplied. | | | | | | | | |
| Technological
Characteristics | 3.75mm, 4.2mm, 5mm
Lengths: 8, 10, 11.5, 13,
16m | Material composition:
Titanium alloy
Surface treatment:
Sandblasting
"aluminum oxide
particles" and Acid
Etching HCl & H₂SO₄
Dimensions/angulations

  1. Implants: Diameter
    3.75mm, 4.2mm, 5mm | Internal hex connection | Material composition: Titanium
    Alloy
    Surface treatment: Sandblasting
    "aluminum oxide particles" and Acid
    Etching HCl & H₂SO₄
    Dimensions/angulations
  2. Implants: Diameter: 3.75 – 6mm,
    Lengths: 8, 10, 11.5, 13, 16mm
  3. Abutments 15° - 25°, Diameter 3.9 -
    4.5mm, Lengths: gum height 1-4mm | Diameter 3.75:
    8, 10,11.5, 13, 16mm | Material composition: Titanium
    Alloy
    Surface treatment: Sandblasting
    "aluminum oxide particles" and Acid
    Etching HCl & H₂SO₄
    Dimensions/angulations
  4. Implants: Diameter: 3.25-6mm,
    Lengths:
    Diameter 3.3:
    10,11.5, 13, 16mm
    Diameter 3.75: | | | |
    | 2. Abutments 15° - 25° | | Diameter 4.2:
    6, 8, 10,11.5, 13, 16mm | | | | | | | |

:

·

.

.

·

5

Image /page/5/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 circle is the word "PALTOP" in a bold, sans-serif font.

With you to the TOP

.

6

Image /page/6/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth icon on the left, followed by the text "PALTOP" in a bold, sans-serif font. The word "PALTOP" also has a trademark symbol next to it.

With you to the TOP

| Diameter 4-5.5mm,
Lengths: gum height 1-
3mm
Internal Hex
Connection | Diameter 5 & 6:
6, 8, 10,11.5, 13, 16mm
2. Abutments: 15° - 25°, Diameter 4-
5.5mm, Lengths: gum height 1-4mm
Internal hex connection |

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The Paltop Dental Implant System has the following similarities to predicate devices:

  • Has the same intended use ●
  • Uses the same operating principle .
  • Incorporates the same basic design .
  • Incorporates the same materials .
  • Has similar packaging .
  • Is sterilized using the same procedures .

Non Clinical Tests:

A series of safety and performance testing were performed to demonstrate that the Paltop Advanced Dental Solutions Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance, surface analysis and biocompatibility.

The device complies with the following standards:

    1. FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
  • .2. ISO 14801:2007 "Dentistry Implants Dynamic fatigue test for endosseous dental implants".
    1. ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
    1. ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
    1. ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments
    1. ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry.
    1. ASTM F746 04(2009) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials.

7

Image /page/7/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, geometric font. A small registration mark is visible to the upper right of the "P" in "PALTOP".

With you to the TOP

    1. ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
      All these tests demonstrate that the Paltop Advanced Dental Solutions Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

Clinical Tests

A clinical evaluation has been performed based on a literature review.

From current knowledge this literature evaluation of the Paltop Dental Implant System provides sufficient evidence:

  • The presented studies demonstrate that titanium-based dental implants can be . installed safely in human patients with a very high overall success rate.
  • The present studies demonstrate compliance of the device in question with the . essential requirements (in particular regarding safety and performance) under normal conditions of use.
  • That the device performs as intended by the manufacturer; �
  • That the device does not pose any undue safety concerns to either the recipient . or end-user.
  • That any risks associated with the use of the device are acceptable when . weighed against the benefits to the patient.

Summary:

Based on performance testing results, and compliance to performance standards Paltop Advanced Dental Solutions Ltd. believes that the Implant System is substantially equivalent to its predicates without raising new issues of safety or effect

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person embracing another, representing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. 5 Hashita Street Caesarea ISRAEL 30889

Re: K112795

Trade/Device Name: Paltop Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 28, 2012 Received: April 9, 2012

Dear Ms. 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.

APR 2 0 2012

9

Page 2 – Ms. Hammer-Topaz

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use

510(k) Number (if known): K12795

Device Name: PALTOP Advanced Dental Solutions System

Indications for Use:

The Paltop Dental Implant 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. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Prescription Use > AND/OR Over-The-Counter 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Premarket Notification510(k) Number:/ 12112795 page.4-2