(90 days)
Not Found
No
The document describes a physical dental implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The Uno - One Piece Screw-Type Dental Implant is a therapeutic device because its intended use is to restore the patient's chewing function by providing support for artificial teeth.
No
The provided text describes a dental implant, which is a prosthetic device used to restore chewing function. There is no mention of the device being used to diagnose any condition or disease.
No
The device description clearly states it is a physical dental implant made of titanium alloy, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Uno - One Piece Screw-Type Dental Implant is a physical device intended for surgical placement in the bone of the jaw to support artificial teeth and restore chewing function. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
The text focuses on the physical characteristics, placement, and function of a dental implant, which is a type of prosthetic device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
Product codes
DZE
Device Description
The Uno - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination.
The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions.
The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion.
The Uno implants are supplied sterile and are intended for single use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws; premolar, cuspid and incisor regions of partially edentulous jaws
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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
APR 2 2 2008
is
510(k) Summary:
Uno - One Piece Screw-Type Dental Implant
Company Name -
MIS - Implants Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL Telephone: +972-4-980-9966 Fax: +972-4-980-9944
Establishment Registration Number: 3004203816
Iman Khorshid Contact Name: Quality Manager Telephone: +972-4-980-9966 Fax: +972-4-980-9944 E-mail: iman@mis-implants.com
US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: mis.service@verizon.net
Date prepared: January 17, 2008
Trade Name: Uno - One Piece Screw-Type Dental Implant
Classification name: Implants, Endosseous, Root Form
Common/usual name: Uno - One Piece Screw-Type Dental Implant
Product Code: DZE
Regulation No.: 872.3640
1
Class: II
Panel identification: Dental Devices Panel
Predicate Device: ZIMMER DENTAL ONE-PIECE IMPLANT from ZIMMER DENTAL INC. , 1900 Aston ave. Carlsbad, CA 92008, cleared under 510(k) no. K052997.
Description of the device:
The Uno - One Piece Screw-Type Dental Implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination.
The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions.
The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion.
The Uno implants are supplied sterile and are intended for single use only.
Indications for Use:
The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment combination.
2
The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment combination. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
Substantial Equivalence:
The Uno - One Piece Screw-Type Dental Implants have the same intended use as the ZIMMER DENTAL ONE-PIECE IMPLANT from ZIMMER DENTAL INC. , 1900 Aston ave. Carlsbad, CA 92008, cleared under 510(k) no. K052997, and have equivalent performance characteristics. Both products are manufactured from the same Titanium alloy. All other technological characteristics are similar and show equivalent performance capabilities. The Uno - One Piece Screw-Type Dental Implants are therefore substantially equivalent to the predicate device.
Conclusion -
The evaluation of the Uno - One Piece Screw-Type Dental Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with a double helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2008
Ms. Iman Khorshid Quality Manager M.I.S. Implants Technologies Limited P.O.BOX 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL
Re: K080162
Trade/Device Name: Uno - One Piece Screw-Type Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Codes: DZE Dated: March 20, 2008 Received: March 31, 2008
Dear Ms. Khorshid:
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 application (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 such additional controls. Existing major regulations affecting vour 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.
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Page 2 - Ms. Khorshid
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 begin 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 vour 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) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
5
K080162
INDICATIONS FOR USE
K080162 510(k) Number (if known):
Uno - One Piece Screw-Type Dental Implant Device Name:
The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated Indications for Use: for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
X OR Prescription Use (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruopp
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number: K080162