(88 days)
No
The description focuses on mechanical components and their physical properties, with no mention of AI/ML terms or functions.
No
The device is described as an "orthodontic bonding base" used to anchor orthodontic forces, which is considered an accessory to orthodontic treatment, not a direct therapeutic device itself. Its function is to facilitate the bonding of an orthodontic bracket, which applies the therapeutic force.
No.
The device is a bonding base used to attach orthodontic brackets to implants for orthodontic treatment, not for diagnosing medical conditions.
No
The device description clearly describes a physical component (orthodontic bonding base) that is screwed onto an implant and has physical features for positioning and bonding. It is not solely software.
Based on the provided information, 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 Function: The described device is a physical component (a bonding base) that is screwed onto a dental implant in the posterior oral cavity. Its function is to serve as an anchor for orthodontic treatment by providing a surface for an orthodontic bracket.
- No Sample Analysis: The device does not involve the analysis of any biological samples taken from the patient. It is a mechanical device used directly within the oral cavity.
Therefore, the device falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The bonding base serves as an attachment surface for the cementing of orthodontic brackets.
The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
Product codes
DZE
Device Description
The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior oral cavity
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)
ITI Titanium Transverse Screw Coping (K943720), ITI Octa Gold Coping (K894844), 3M Unitek orthodontic bands
Reference Device(s)
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
DEC - 2 1997
KA73353
ATTACHMENT 7
510(k) Summary
1
ATTACHMENT 7 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02154 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Linda Jalbert, Director of Regulatory Affairs Contact Person:
2. Name of the Device
Trade Name: Bonding Base Orthodontic Bonding Base Common Name: Accessory to a dental implant (21 CFR 872.3640) Classification Name:
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
ITI Titanium Transverse Screw Coping (K943720) ITI Octa Gold Coping (K894844) 3M Unitek orthodontic bands
4. Description of the Device
The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.
ട. Intended Use of the Device
The bonding base serves as an attachment surface for the cementing of orthodontic brackets.
2
Basis for Substantial Equivalence 6.
The Orthodontic Bonding Base is substantially equivalent to 3M Unitek Orthodontic The Orthodonitic Donaing Daos to babotantially oquivalism to on Children in the ITI Dands, the TTP Thankin Transverstooners on, material and design as follows:
| | Subject
Device | Predicate Devices | | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Orthodontic
Bonding
Base | 3M Unitek
Orthodontic
Bands | ITI Titanium
Transverse
Screw
Coping | ITI Octa Gold
Coping | ITI
Transverse
Screw Gold
Coping |
| Intended
Use | Serve as a base
for orthodontic
attachment | Serve as a
base for
orthodontic
attachment | Serve as a base
for prosthetic
reconstruction | Serve as a base
for prosthetic
reconstruction | Serve as a
base for
prosthetic
reconstruction |
| Materials | Titanium | Stainless Steel | Titanium | gold alloy | gold alloy |
| Design | Heights of 5.5
mm and 6.5 mm.
Width of 6.8 mm.
Internal
icositetrahedron
(24 facets) for
seating on
Octabutment.
Axial screw
channel for
attachment to
abutment. | Tooth-shaped
circular bands
designed in a
range of sizes
to
accommodate
varying tooth
anatomies and
sizes. | Height of 8.0
mm.
Internal
icositetrahedro
n (24 facets) for
seating on
Octabutment.
Transverse
screw channel
for attachment
to abutment | Height of 4.0
mm.
Internal octagon
for seating on
Octabutment.
Axial screw
channel for
attachment to
abutment. | Height of 5.2
mm.
Internal
icositetrahedr
on (24 facets)
for seating on
Octabutment.
Transverse
screw channel
for attachment
to abutment. |
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Ms. Linda Jalbert Director, Requlatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road 02154 Waltham, Massachusetts
Re : K973353 Trade Name: Bonding Base Regulatory Class: III Product Code: DZE Dated: September 4, 1997 Received: September 5, 1997
Dear Ms. Jalbert:
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 regulations 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 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
4
Page 2 - Ms. Jalbert
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 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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
5
| 510(k) Number (if known): | K973353 |
|---|---|
| Device Name: | Bondin base |
| Indications For Use: |
Page ofThe bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Divi- Division of Reproductive, Abdominal, and Radiological Devices Control,
and Division of Reproductive, Abdominal, and Radiological Devices al Devices
| 510(k) Number | K973353 |
|---|---|
| --------------- | --------- |
Prescription Use Vse (Per 21 CFR 801.109)
OR
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
·
(Optional Format 1-2-96)