Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Device Description

Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ, range = 3μ to 10μ).

AI/ML Overview

The provided text is a 510(k) summary for Nobel Biocare's Modified Surface Implant, a dental implant. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

510(k) summaries primarily focus on:

Device Description: What the device is.
Intended Use: What the device is for.
Comparison to Predicate Devices: Showing how the new device is similar to legally marketed devices.
Technological Characteristics: Details about the materials, design, and function.

The document states "The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ, range = 3μ to 10μ)," which describes a characteristic of the device, but it doesn't provide acceptance criteria or a study demonstrating that this characteristic leads to a specific clinical performance outcome.

The provided text only includes:

A. Manufacturer Information: Details about Nobel Biocare USA, Inc.
B. Device Name: Nobel Biocare's Modified Surface Implant.
C. Classification: Endosseous Dental Implant (21 CFR 872.3640).
D. Device Description: Physical characteristics of the implant (threaded, hex-lock, root-form, 3.75-mm diameter, 7-20mm length, titanium oxide layer with specific thickness).
E. Intended Use: Placed in upper or lower jaw to support prosthetic devices, restore chewing function, using two-stage or single-stage surgical procedures. Specifically notes conditions for immediate loading in single-stage procedures (at least four implants, splinted with a bar, predominantly in anterior mandible, good initial stability).
F. Comparison to Predicate Device(s): Tables comparing the new device to Sargon Cylindro-Blade Implant (K930071) and Straumann ITI "One Part" Implant (K984104) based on attributes like design, placement method, body material, coating, length, diameter, packaging, and sterility.

In summary, there is no study described in this 510(k) summary that provides acceptance criteria, device performance, sample sizes, expert details, or ground truth information as requested. It is a submission for regulatory clearance based on substantial equivalence to existing devices, not a clinical trial report.

Summary

{0}------------------------------------------------

K993595

Section 8 510(k) Summary

Nobel Biocare USA Letterhead

510(k) Summary

A. Manufacturer Information:

Submitter's Name:	Nobel Biocare USA, Inc.
Submitter's Address (U.S. Representative/Distributor):	22825 Eastpark DriveYorba Linda, CA 92887 USA
Contact's Name:	Jeff Hausheer, Ph.D., Regulatory Affairs Specialist
Contact's Telephone No.:	714-282-4800, extension 7832
Date Prepared:	October 1999
Address (Manufacturer):	Nobelpharma Production ABDimbovagen 2Karlskoga S-691-51SWEDEN
Manufacturer's Registration No.	9611993

B. Device Name:

Common Name: Dental Implant Trade Name: Nobel Biocare's Modified Surface Implant

C. Classification:

Classification Name: Endosseous Dental Implant Classification Number: DZE Classification Citation: 21 CFR 872.3640

Page 1 of 4

Nobel Biocare USA - October 1999

{1}------------------------------------------------

Section 8 510(k) Summary (continued)

D. Device Description:

E. Intended Use:

F. Comparison to the Predicate Device(s):

The following table provides a comparison of the technological characteristics of the predicate devices and Nobel Biocare's Modified Surface Implant

Page 2 of 4

Nobel Biocare USA - October 1999

{2}------------------------------------------------

Section 8 510(k) Summary (continued)

Table 8.1 Identification of the Predicate Devices and the Submitted Device, Nobel Biocare's Modified Surface Implant

ImplantProduct	510(k) #(and Manufacturer)
Modified Surface Implant	K # pending
Cylindro-Blade Implant	K930071 (Sargon)
ITI "One Part" Implant	K984104 (Straumann)

Page 3 of 4

{3}------------------------------------------------

4-8

Section 8 510(k) Summary (continued)

Table 8.2

Technology: Comparison of the Predicate Devices and the Submitted Device, Nobel Biocare's Modified Surface Implant

Attribute/ Characteristic	Predicate No. 1Sargon Cylindro-Blade Implant	Predicate No. 2 Strau-mann ITI Implant	Nobel Biocare's ModifiedSurface Implant(Submitted Product)
Design	Threaded, tapered, non-solid (hollow),flanged root-form implant	Threaded, root-form	SAME predicate #2)
Placement Method	Single stage surgery, immediate load	Single stage surgery,immediate load	SAME
Body Material	Titanium alloy	Commercially pure tita-nium	SAME (predicate #2)
Coating	None	None	SAME
Length (mm, min.-max.)	10 mm to 18 mm	Unknown	7 mm to 20 mm*
Diameter (mm)	Available in 1 tapered design only; its di-ameter ranges from 3.8 to 4.1 mm.	Unknown	3.75 mm
Packaging	Vial	Unknown	Glass vial in blister pack
Sterility	Unknown	Unknown	Sterile

Page 4 of 4

Nobel Biocare USA - October 1999

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

ﺔ ﺑﻠﺪﻳ

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2000

Jeff Hausheer, Ph.D. Requlatory Affaris Specialist Nobel Biocare USA, Incorporated 22895 Eastpark Drive 92887 Yorba Linda, California

Re: K993595 Nobel Biocare's Modified Surface Implant Trade Name: Requlatory Class: III Product Code: DZE Dated: October 22, 2000 Received: October 25, 2000

Dear Dr. Hausheer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{5}------------------------------------------------

Page 2 - Dr. Hausheer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one rogalable. Choroson, (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{6}------------------------------------------------

K93595

Section 1 Indications for Use

Page 1 of 1

1171

510(k) Number (if known): K9XXXXX

Device Name: Nobel Biocare's Modified Surface Implant

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
(Division Sign-Off)Division of Dental, Infection Control,and General Hospital DevicesK993595510(k) Number	NOBEL BIOCARE USA -	CTOBER 1999

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.