(22 days)
No
The document describes a dental implant system and its modifications, focusing on materials, interfaces, and mechanical testing. There is no mention of AI or ML technology.
No.
The device is a dental implant system used for supporting dental prostheses, which is a structural and restorative function, not a therapeutic one.
No
Explanation: The device description states that the product is an "implant concept" and includes "components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories". Its intended use is "for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single toolh implantation use." This indicates it is a prosthetic device for dental restoration, not a device used to diagnose a condition.
No
The device description explicitly states it includes "all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories," indicating physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being implanted into the body (edentulous and partially edentulous ridges, single tooth implantation) for the support of a dental prosthesis. This is an in-vivo application, not an in-vitro diagnostic test performed on samples outside the body.
- Device Description: The description details components for laboratory and prosthetic work related to dental implants and bridge supports. This aligns with a medical device used in dental procedures, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a dental implant system and related components, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single tooth implantation use.
Product codes
DZE
Device Description
The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fully edentulous ridge; partially edentulous ridge
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)
In vice testing (mechanical and fatigue tests) has neen performed to assess the validity of the design and the validity of the interface with the implace such as external has. internal hex, internal or external tapered conc. Additionally, careful screw design analysis has been carried out and a detailed torque angle signature analysis confirmed the validity and design of Cresco solutions.
Clinical testing demonstrate the long-term validity of the concept not only on Cresce platform, but also on external hex and internal tapered surface type platforms, such as Branemark and ITI systems.
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
SEP 2 1 7004
510K(k) SUMMARY
SUBMIT TER.
Cresco Tit Systems AB Dobeinsgatan 7 Kristianstad. 29:25 Sweder
DATE PREPARED:
DEVICE NAME:
August 25, 2004
Modification to the CRESCO TI® IMPLANT
CLASSIFICATION NAMES: CONCEPT
CRESCO TI® IMPLANT CONCEPT
Endosseous Dental Implant & AccessoriesT
Device Description:
PREDICATE DEVICE:
The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),
Predicate Devices:
There has been a device previously cleared by the FDA in the following 510(K) Notification indicated for use as a endosseous dental implant and associated accessories:
| Device | 510(k) Document
Number | Date Cleared | Indications |
|-------------------------------|---------------------------|------------------------|-----------------------------------------------|
| Cresco Ti® Implant
Concept | K981052 | December 18th,
2001 | Endosseous
Dental Implant
& Accessories |
We therefore consider the proposed devices substantially equivalcet and identical to existing products/predicate devices either currently or in the past, in commercial distribution in the United States
1
Intended Ilse:
Cresco Ti" Implant Concept Indications:
The Cresco Tits Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis: b) for implantation into the partially edentulous ridge for support of a dental prosthesis: a c) for single tooth implantation use
Technological Characteristics:
Technologically, both the proposed and predicate devices are the same and are indicated for use as endosseous dental implants and accessories. The modification to the above listed endosseous dental implant and accessories, extends the compatibility of the Cresco TI screws and bridge supports to additional designs of dental implants provided by manufacturer's other than Cresco Ti Systems AB. Additionally, both devices utilize accessories for abutnents, screws and bridge supports which are comceted to the endosseous dental implants.
Summary of Non-Clinical Tests:
In vice testing (mechanical and fatigue tests) has neen performed to assess the validity of the design and the validity of the interface with the implace such as external has. internal hex, internal or external tapered conc. Additionally, careful screw design analysis has been carried out and a detailed torque angle signature analysis confirmed the validity and design of Cresco solutions.
Clinical Test Results:
Clinical testing demonstrate the long-term validity of the concept not only on Cresce platform, but also on external hex and internal tapered surface type platforms, such as Branemark and ITI systems.
Conclusions:
Any differences between the two devices do not raise new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines extending from its body, representing the promotion of health, well-being, and human services. 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
SEP 2 1 2004
Ms. Jeanette Bengtsson Quality Assurance/ Cresco Ti Systems AB Döbelnsgatan 7 291 25 Kristianstad, Sweden
Re: K042354
Trade/Device Name: Modification to: Cresco T1® Implant Concept Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 1, 2004 Received: August 31, 2004
Dear Ms. Bengtsson:
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 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. Bengtsson
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 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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Ruano
Chi. L.P., 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
4
Indications for Use
510(k) Number (if known): K042354 Cresco Tr® Implant Concept Device Name: Indications for Use:
The Cresco Ti® Implant Concept is intended
a) for implantation into the fully edentulous ridge for the support of a dental prosthesis;
b) for implantation into the partially edentulous ridge for support of a dental prosthesis;
c) for single toolh implantation use.
Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
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 Runn
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K02
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