K Number

Device Name

PROVISIONAL DENTAL IMPLANT SYSTEM

Manufacturer

NOBEL BIOCARE UAS INC

Date Cleared

1999-03-01

(90 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

The intended use for this device is to serve as temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

Device Description

Nobel Biocare's "Immediate Provisional Implant" is designed to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Nobel Biocare's threaded titanium "Immediate Provisional Implant" is available in widths of 2.8 millimeters and 3.2 millimeters, and lengths ranging from 14 millimeters to 22 millimeters.

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

MTI Implant, Mini Dental Implant

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and clinical performance of a temporary dental implant, with no mention of AI or ML.

Therapeutic

No.
The device provides temporary support for prosthetic devices and protects permanent implants, but it does not directly treat a disease or condition in the body.

Diagnostic

The device is described as an "Immediate Provisional Implant" intended to provide temporary support for prosthetic devices during the healing phase of permanent dental implants. Its function is structural support and not to diagnose any condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "threaded titanium 'Immediate Provisional Implant'" available in specific widths and lengths, indicating it is a physical hardware device.

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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description and Intended Use: The description clearly states the device is a threaded titanium implant designed to provide temporary support for prosthetic devices during the healing phase of permanent dental implants. This is a surgical/implantable device used directly in the body, not for testing samples outside the body.

The information provided aligns with a medical device used in a surgical procedure, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Nobel Biocare's "Immediate Provisional Implant" is indicated for use as a temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

The intended use for this device is to serve as temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

Product codes

DZE

Device Description

Nobel Biocare's "Immediate Provisional Implant" is designed to provide temporary support for prosthetic devices during the healing phase of permanent root form implants.

Natural dentition is composed of a subgingival root and a supragingival crown. Root form implant designs in existence are intended to mimic this structure, and to aid the patient by allowing restoration of natural masticastory function. During the period while permanent endosseous implants are healing, all loading of the permanent implants must be avoided. Consequently, patients have poor quality masticastory function, if any such function at all during the healing period.

Temporary provisional implants, placed concurrently with the permanent implants, and on which a provisional prosthesis can be placed, provide the patient masticastory function during the permanent implant-healing period, and protect the permanent implants from pre-mature loading and/or micromovement.

The "Immediate Provisional Implant" is designed to serve as a temporary root of the provisional artificial tooth, and the provisional abutment/prosthetic is designed to serve as the temporary crown. After the permanent implant-healing period is completed, the provisional prosthesis and temporary implants are removed, and a permanent abutment and prosthesis fitted to the permanent implants.

Nobel Biocare's threaded titanium "Immediate Provisional Implant" is available in widths of 2.8 millimeters and 3.2 millimeters, and lengths ranging from 14 millimeters to 22 millimeters.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

In a clinical trial, Nobel Biocare's "Immediate Provisional Implant" successfully provided support for provisional prosthetic devices while simultaneously protecting the permanent implants from premature loading during their healing period. Following healing of the permanent implants, the "Immediate Provisional Implants" were removed, abutments affixed to the permanent implants, and a permanent prostheses attached. Use of the Nobel Biocare "Immediate Provisional Implant" did not affect the success of the permanent implants and the associated permanent implant supported restorations.

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

Not Found

Predicate Device(s)

Dentatus' "MTI Implant", Sendax's "Mini Dental Implant"

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

March 1, 1999

P.01
K984287

March 1, 1999

Food and Drug Administration CDRH, ODE Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850

Attention: Angela Blackwell, Dental Devices Branch

Re: 510(k) K984287 Nobel Biocare's "Immediate Provisional Implant"

Dear Ms. Blackwell:

Enclosed are two original copies of Section 7, 510(k) K984287, Immediate Provisional Implant, revised to reflect changes to the 510(k) that you, as the reviewer, had requested.

If you require any other information, please let me know.

Sincerely,
Jeff Hausler Ph.D.

Jeff Hausheer, Ph.D. Regulatory Affairs Specialist Nobel Biocare USA

Encl.: Section 7 (revised), 510(k) K984287, Immediate Provisional Implant

P. Gasser CC: 510(k) file K984287 K. Rendon
Nobel Biocare USA, Inc.

22895 Eastnark Drive, Yorba Linda, CA 9288 12 lenhone (714) 282-4800 Fax (714) 998-9236

Original 510(k) Immediate Provisional Implant

Section 7 510(k) Summary

Manufacturer Information:

Submitter's Name:	Nobel Biocare USA
Address:	22895 Eastpark Drive
Yorba Linda, CA 92887
U.S.A.
Contact's Name:	Jeff Hausheer, Ph.D.
Regulatory Affairs Specialist
Telephone Number:	714-282-4800, extension 7832
Date Prepared:	March 1999

Device Names:

Common Name:	Dental Implant
Trade Name:	Immediate Provisional Dental Implant System
Classification Name:	Endosseous Implant

Predicate Device:

Substantial equivalence is claimed to Dentatus' "MTI Implant" and Sendax's "Mini Dental Implant".

Device Description:

Nobel Biocare's "Immediate Provisional Implant" is designed to provide temporary support for prosthetic devices during the healing phase of permanent root form implants.

P.02

Original 510(k) Immediate Provisional Implant

Section 7 510(k) Summary (continued)

Device Description (continued):

Scientific concepts:

Characteristics:

Nobel Biocare's threaded titanium "Immediate Provisional Implant" is available in widths of 2.8 millimeters and 3.2 millimeters, and lengths ranging from 14 millimeters to 22 millimeters.

Original 510(k) Immediate Provisional Implant

Section 7 510(k) Summary (continued)

Intended Use:

Nobel Biocare's "Immediate Provisional Implant" is indicated for use as a temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

Comparison to Predicate:

The following table (Table 7.1) provides a comparison of the technological characteristic of Nobel Biocare's "Immediate Provisional Implant" to the predicate provisional implants, Dentatus' MTI Implant and Sendax's Mini Dental Implant.

TABLE 7.1
Comparison of Nobel Biocare's "Immediate Provisional Implant"
to the Predicate Devices

| Characteristic | Dentatus' MTI
Implant | Sendax's Mini Dental
Implant | Nobel Biocare's
"Immediate Provisional
Implant" |
|----------------|--------------------------|---------------------------------|-------------------------------------------------------|
| Body Material | Titanium | Titanium & Titanium
alloy* | SAME (Titanium) |
| Geometry | Threaded | Threaded | SAME |
| Length | 17 mm & 20 mm | 14, 17, 19, and 22 mm | SAME (14 to 22 mm) |
| Diameter | 1.8 mm | 1.8 mm | 2.8 mm & 3.2 mm** |
| Sterility | Non-sterile | Unknown | Sterile |

· = Sendax's 510(k) cleared for both commercially pure titanium and titanium alloy

** = Nobel Biocare submitted clinical data supporting 2.8 mm and 3.2 mm.

Performance Data:

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three faces overlapping each other. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 1999

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

Re: K984287 Provisional Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: November 20, 1998 Received: December 1, 1998

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 Regulations, 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 regulation may result in regulatory 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.

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 requlation (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
premarket notification" (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

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

Enclosure

510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

Provisional Dental Implant System DEVICE NAME:

INDICATIONS FOR USE:

CATIONS FOR USE:
The intended use for this device is to serve as temporary The intended use for this devices during the support for provisional proscheore as as a love in the

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter-Use
(Optional Format 1-2-96) |

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

(Division Sign-Off) familler Scott for Susan Plummer Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K984287