(182 days)
No
The summary describes a standard dental implant made of titanium with no mention of AI or ML technology.
Yes
The device is intended to restore a patient's chewing function, which is a therapeutic purpose.
No
The device description clearly states its purpose as supporting prosthetic devices and restoring chewing function through surgical procedures. There is no mention of its use for diagnosis, detection, or assessment.
No
The device description clearly states that the device is a physical implant fabricated from titanium, not software.
No, 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 and Intended Use: The provided text clearly describes a dental implant intended to be surgically placed in the jawbone to support prosthetic teeth and restore chewing function. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
The information provided focuses on the physical characteristics of the implant, its surgical placement, and its function in supporting a prosthesis. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
Selected Brånemark System® implant products (those identified in Table 7.1, below) are intended to be placed in the upper or lower jaw 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 a single stage surgical 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.
Product codes
DZE
Device Description
Brånemark System® dental implants are threaded, root-form implants fabricated from ASTM grade 1 "commercially pure" titanium. They are available in diameters of 3.75 mm and 4.0 mm, and are available in lengths ranging from 10 mm to 21 mm. Research studies have demonstrated that titanium is biocompatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, anterior mandible (between the mental foramina)
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)
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
FEB 2 9 2000
Nobel Biocare USA, Inc. 510(k) Notification: Immediate Loading Indication June 21, 1999
Section 7 510(k) Summary
A. Manufacturer Information:
Nobel Biocare USA. Inc. Submitter's Name: Address: 22725 Savi Ranch Parkway U.S. Representative/Distributor Yorba Linda, CA 92887, USA
Contact's Name: Contact's Telephone No .: Date Prepared:
Jeff Hausheer, Ph.D., Regulatory Affairs Specialist 714-282-4800, extension 7832 June 1999
Address-Manufacturer:
Nobelpharma Production AB Dimbovagen 2 Karlskoga S-691-51, Sweden Manufacturer Registration Number: 9611993
B. Device Name:
Common Name:
Dental Implant
Trade Name:
Brånemark System® Implants Indicated For Loading Immediately Following Implant Placement (see table below) (i.e., within 2 to 3 weeks following implant placement)
| Brånemark System®: Implant Product
Family Name | Dimensions: Diameter &
Range of Lengths (mm) |
|---------------------------------------------------|-------------------------------------------------|
| Standard Series Implants (3.75) | 3.75 x 10-20 mm |
| Standard Series Implants (4.0) | 4.0 x 10-18 mm |
| Mk II Self-Tapping Implants (3.75) | 3.75 x 10-18 mm |
| Mk II Self-Tapping Implants (4.0) | 4.0 x 10-18 mm |
| Self-Tapping Implants | 3.75 x 10-18 mm |
| Conical Self-Tapping Implants | 3.75 x 13-21 mm |
| Mk IV Self-Tapping Implants | 4.0 x 10-18 mm |
Classification:
| Classification Name: | Endosseous Dental Implant |
|---|---|
| Classification Number: | DZE |
| Classification Citation: | 21 CFR 872.3640 |
Page 1 of 3
1
Section 7 510(k) Summary (continued)
C. Device Description:
Description: Brånemark System® dental implants are threaded, root-form implants fabricated from ASTM grade 1 "commercially pure" titanium. They are available in diameters of 3.75 mm and 4.0 mm, and are available in lengths ranging from 10 mm to 21 mm. Research studies have demonstrated that titanium is biocompatible.
D. Intended Use:
Indications For Use: Selected Brånemark System® implant products (those identified in Table 7.1, below) are intended to be placed in the upper or lower jaw 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 a single stage surgical 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.
| Brånemark System®
| Implant Product Family | Diameter | Range of Lengths | 510(k) |
|---|---|---|---|
| Mk II Self-Tapping | 3.75 mm | 10-18 mm | K925762 |
| Mk II Self-Tapping | 4.0 mm | 4.0 x 10-18 mm | K945398 |
| Standard Series | 3.75 mm | 3.75 x 10-20 mm | K925765 |
| Standard Series | 4.0 mm | 4.0 x 10-18 mm | K925764 |
| Self-Tapping | 3.75 mm | 3.75 x 10-18 mm | K925762 |
| Conical Self-Tapping | 3.75 mm | 3.75 x 13-21 mm | K925760 |
| Mk IV Self-Tapping | 4.0 mm | 4.0 x 10-18 mm | K974828 |
| Table 7.1 |
|---|
| 510(k) Notification: |
| Brånemark System® Implant Products Indicated For Immediate Loading |
2
Nobel Biocare USA, Inc. 510(k) Notification: Immediate Loading Indication June 21, 1999
Section 7: 510(k) Summary (continued)
E. Comparison to the Predicate Device(s): .
Comparison Of The Predicate Devices And The Branemark System® Implant Products For Which Clearance Of An Immediate Load Indication Is Sought
| Predicate Product | Predicate Product | Submitted Product | |
|---|---|---|---|
| Characteristic | Straumann ITI Implant (510(k) | ||
| K984104) | Sargon Cylindro-Blade Implant [510(k) | ||
| K930071] | Brånemark System® Implant Products** | ||
| Intended Use | intended to be placed in the | ||
| maxillary and/or mandibular | |||
| arches to support prosthetic | |||
| restorations in edentulous or | |||
| partially edentulous patients. | Intended to act as a replacement for | ||
| missing teeth by providing the means for | |||
| fixation of dentures, removable bridgework, | |||
| or prosthetic teeth. | (Functionally, the same): intended to be placed | ||
| in the upper or lower jaw to support prosthetic | |||
| devices such as artificial teeth, and to restore | |||
| patient's chewing function. | |||
| Indication | Immediate Load | Immediate Load | Same |
| Design | threaded, root-form implant | a threaded, tapered, non-solid (hollow), | |
| flanged root form implant | threaded, root-form implants | ||
| Placement Method | Single stage surgery | Single stage surgery | Same |
| Material | Commercially pure titanium | Titanium alloy | Commercially pure titanium |
| Coating | None | None | None |
| Length (mm, min.- | |||
| max.) | Unknown | 10mm to 18 mm | 10mm to 21 mm |
| Diameter (mm) | Unknown | Available in 1 tapered design only, ran | |
| Available in one tapered design only; its | |||
| diameter ranges from 3.8 mm to 4.1 | |||
| ranging from 3.8 mm to 4.1 mm | 3.75 mm and 4.0 mm | ||
| Precautions & | |||
| Warnings | Unknown | None | None |
| Packaging | Unknown | Vial | Glass ampoule in peel-open blister pack |
| Provided Sterile? | Unknown | Unknown | Yes (dry heat = glass ampoule; steam = blister |
| pack) |
= See Table 2.A.1 for identification, dimensions, and 510(k) numbers of each product
Page 3 of 3
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved shapes that could be interpreted as abstract representations of human figures or flowing elements.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2000
Dr. Jeff Hausheer Requlatory Affairs Specialist Nobel Biocare USA, Inc. 22895 Eastpark Drive Yorba Linda, CA 92887
Re: K992937 Brånemark System® Implants Trade Name: Requlatory Class: III Product Code: DZE Dated: December 2, 1999 Received: December 6, 1999
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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
4
Page 2 -Dr. Hausheer
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4690. 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,
Patricio Cavente/for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Nobel Biocare USA. Inc. 510(k) Notification: Immediate Loading Indication June 21, 1999
Section 10 Indications for Use
Page 1 of 1
50
510(k) Number (if known): K ------
Device Name:
Selected Brånemark System® Implant Products:
| Mk II Self-Tapping | K925762 |
|---|---|
| Mk II Self-Tapping | K945398 |
| Standard Series | K925765 |
| Standard Series | K925764 |
| Self-Tapping | K925762 |
| Conical Self-Tapping | K925760 |
| Mk IV Self-Tapping | K974828 |
Indications For Use: Selected Brånemark System® implant products (those identified in the preceding section, "Device Name") are intended to be placed in the upper or lower jaw 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 surqical procedure.
If a single stage surgical 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 anchoragel can most often be obtained.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) n of Dental, Infection
Numbers Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use __ L OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)