(25 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an implantable anchorage point for orthodontic appliances, which facilitate tooth movement. It does not directly provide therapy.
No
The device is an implant used to provide an anchorage point for orthodontic appliances. Its purpose is to facilitate tooth movement, not to diagnose a condition.
No
The device description clearly states it is a "one piece, threaded self-tapping titanium screw implant," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The Straumann Palatal Implant is a physical implant placed inside the body (in vivo) to provide anchorage for orthodontic appliances. It is a surgical device, not a diagnostic test performed on a specimen.
The provided information clearly describes a device used for a therapeutic purpose (facilitating orthodontic movement) by being surgically implanted, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Product codes
OAT
Device Description
The Straumann Palatal Implant is a modification of the Straumann Ortho Implant. The Palatal Implant is a one piece, threaded self-tapping titanium screw implant with an insertion depth of 4 mm. The design of the Palatal Implant is very similar to the predicate Straumann ortho implants and TE dental implants. The surface of the Palatal implant is the grit blasted, acid etched SLA surface, which is the same as that of the predicate devices. The design of the endosseous part of the palatal implant is the same as the current Straumann TE implants, originally cleared under K012757.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-sagittal or paramedian area of the hard palate or in retromolar positions
Indicated Patient Age Range
adults and juveniles age 12 and older. In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the palatal implants should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.
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
Not Found
Key Metrics
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 3
2006
510(k) Summary
Applicant's Name and Address 1.
Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0031 Fax Number: Contact Person: Elaine Alan Regulatory Affairs
Name of the Device 2.
| Trade Name: | Straumann Orthosystem |
|---|---|
| Common Name: | Orthodontic implants |
| Classification Name: | Endosseous dental implants |
| 21 CFR 872.3640 |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
Straumann Orthosystem, originally cleared under K982509 and K040469 Straumann TE Dental Implants, originally cleared under K012757.
4. Description of the Device
The Straumann Palatal Implant is a modification of the Straumann Ortho Implant. The Palatal Implant is a one piece, threaded self-tapping titanium screw implant with an insertion depth of 4 mm. The design of the Palatal Implant is very similar to the predicate Straumann ortho implants and TE dental implants. The surface of the Palatal implant is the grit blasted, acid etched SLA surface, which is the same as that of the predicate devices. The design of the endosseous part of the palatal implant is the same as the current Straumann TE implants, originally cleared under K012757.
Intended Use of the Device ഹ
The Palatal Implant is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
1
Basis for Substantial Equivalence 6.
The subject Palatal implant and accessories are substantially equivalent to the previously cleared Straumann Orthosystem and Straumann TE implants. The intended use is identical to the predicate Orthosystem. The Palatal implant is indicated for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
The subject Palatal implant has the same material composition and the same surface treatment as previously cleared Straumann implants. In addition, the design of the implant and accessories is similar to, and in some respects identical to, the predicate devices.
Susan Runge
Preveral Hospital.
KOLCOLO
Prescription Use
(Per 21 CFR 801.109)
510(k) Straumann New Submerged Implant ()1/06/06 Page 42 of 42
2
Image /page/2/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 an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2007
Institut Straumann AG C/O Ms. Elaine Alan Regulatory & Clinical Affairs Straumann Manufacturing 60 Minuteman Road Andover, Massachusetts 01810
Re: K060062
Trade/Device Name: Straumann Implant for the Orthosystem Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: January 6, 2006 Received: January 9, 2006
Dear Ms. Alan:
This letter corrects our substantially equivalent letter of February 3, 2006.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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, 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Ms. Alan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276- _ (see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Snugie Y. Michael Davis.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name:
Straumann Palatal Implant for the Orthosystem
Indications for Use:
The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Palatal implants can be used in adults and juveniles age 12 and older. In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the palatal implants should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.
Susan Rose
(Division Sic.n-Off) Division of Anesthestology, Ceneral Hospital Infection Control, Dental Devices
510(k) Number: K060066
Prescription Use
(Per 21 CFR 801.109)
510(k) Straumann Palatal Implant Page 6 of 42