(62 days)
Not Found
No
The summary describes a dental implant with a specific surface treatment and its intended use, without mentioning any computational or algorithmic components related to AI or ML.
Yes
The device is described as an implant used to restore patient esthetics and chewing function, which addresses a health-related condition (edentulism) by replacing missing teeth. This aligns with the definition of a therapeutic device.
No
The description states the device is an endosseous implant used to support prosthetic devices, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical implant made from titanium with a surface treatment, intended for surgical placement. It is a hardware device, not software.
Based on the provided text, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Nobel Biocare TiUnite® Implants are "root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches." This describes a surgically implanted medical device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use is to "provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function." This is a therapeutic and restorative function, not a diagnostic one.
The text focuses on the physical properties of the implant, its surgical placement, and its interaction with bone for support and function. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TilUnite® Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
TiUnite® implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite® implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Nobel Biocare TiUnite" Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
Til hite Implants machined from titanium and have a surface treatment consisting of a thin, uniform titanium oxide (TiUnite") layer. Nobel Biocare TiUnite Implants are available with a straight or tapered contour.
Nobel Biocare TiUnite" Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.
Due to a more rapid formation and greater amount of bone to implant contact during healing. Nobel Biocare's TiUnites surfaced implants result in faster and stronger ossecuntegration and better maintenance of the initial implant stability than machined titanium implants. When piaced in soft bone and immediately loaded, the faster and stronger osseointegration of Nobel Biocare's TiUnites surfaced implant results in a higher success rate compared to machined implants
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
Not Found
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.
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
§ 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
510(k) Summary of Safety and Effectiveness 1.4
MAY 1 9 2005
| Submitted by: | Herbert Crane
Manager, Regulatory Affairs |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 5074 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | March 18, 2005 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary
or Model Name: | TiUnite™ Implants |
| Legally Marketed Device(s): | Nobel Biocare Endosseous Implants (K041661) |
Device Description:
Nobel Biocare TiUnite" Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
Til hite Implants machined from titanium and have a surface treatment consisting of a thin, uniform titanium oxide (TiUnite") layer. Nobel Biocare TiUnite Implants are available with a straight or tapered contour.
Nobel Biocare TiUnite" Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.
Due to a more rapid formation and greater amount of bone to implant contact during healing. Nobel Biocare's TiUnites surfaced implants result in faster and stronger ossecuntegration and better maintenance of the initial implant stability than machined titanium implants. When piaced in soft bone and immediately loaded, the faster and stronger osseointegration of Nobel Biocare's TiUnites surfaced implant results in a higher success rate compared to machined implants
Indications for Use:
Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TilUnite® Implants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
TiUnite implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability. faster and stronger osseointegration, and higher success rates
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
MAY 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Mr. Herbert Crane Manager Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K050705
Trade/Device Name: TiUnite® Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: March 17, 2005 Received: March 18, 2005
Dear Mr. Crane:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your becares researce is substantially equivalent (for the referenced above and have determined are to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to that bay been reclassified in accordance with the forcement Amendinents, or to de vices that have obct (Act) that do not require approval of a prematice the Federal Food, Drug, and Cosment 1 10 ( 16) - 16) - 16, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 approval application (1 Mr ). - Four my - Four - San - San - Sat include controls provisions of the rich - 110 gisting of devices, good manufacturing practice, requirements for animons against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see ass rolling controls. Existing major regulations affecting (PMA), it may of subject to Such adaments. Title 21, Parts 800 to 898. In the Cl., Parts 800 to 898. In your device can be found in the Oode of receined in the Federal Register.
2
Page 2 - Mr. Crane
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualice of a babound. Vice complies with other requirements mean that FDA has made a decemmanent and regulations administered by other Federal agencies. of the Act of ally rederal statues and regulations, but not limited to: registration it You must comply with an the Het brequired (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), laceming (21 CFR Pat 820), regulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin mailing of substantial equivalence of your device to a premarket notification. The PDA midness of bassification 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 Patt 801), If you desire specific advice for your do records on the Also, please note the regulation prease contact the Office of Ochiphants and entification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on and Consumer Assistance at its toll-free Division of Binas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: TiUnite® Implants
Indications For Use:
dications I of Or Obe.
Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to the surgical tooth, i Nobel Biocare Titlnite® Implants are foot-omr enobsedds in includes, such as an atificial toth, in
bone of the upper or lower jaw arches to proxtins . Nohol Rincere , such as bone of the upper or lower jaw arches to provide suppor Til bith Implants are indicated for order to restore patient esthetics and chewing function. Nobel Biocare Titlenter Intent malants
single or multiple unit restorations in splinted or non-splinted the intilal single or multiple unit restorations in splinted of nor-splined applications working the initial stability requirements
may be placed immediately and put into immediate funct may be place -----------------------------------------------------------------------------------------------------------------------------------------------------------------
TiUnite® implants are indicated for use in soft bone whenever immediate or early bading is applied. The TiUnite® implants are indicated for use in Sol bone indications because bone formation is more rapid and Tillnite® implants are preferred in these soft bother maintenance of initial implant stability, faster greater than on midonix.
and stronger osseointegration, and higher success rates.
Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penn
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
Page 1 of 1
510(k) Number.