(104 days)
Not Found
No
The summary describes a standard dental implant system and its components, with no mention of AI or ML capabilities. The performance studies focus on material properties and mechanical testing, not algorithmic performance.
Yes
The device is a dental implant system indicated for use in support of crowns, bridges, or overdentures, which are therapeutic interventions to restore dental function.
No
This device is a dental implant system used for supporting crowns, bridges, or overdentures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like dental implants, abutment systems, and surgical/restorative instrumentation (depth gauges, drivers, etc.), indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a dental implant system, consisting of implants, abutments, and surgical/restorative instrumentation. These are devices that are surgically implanted into the body or used to facilitate the implantation and restoration process.
- Intended Use: The intended use is to support crowns, bridges, or overdentures in edentulous or partially edentulous areas. This is a structural and restorative function within the body, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the Regular Diameter Single Stage TPS Dental Implant System is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- The Regular Diameter Single Stage TPS Dental Implant System is indicated for use . in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.
Product codes
DZE
Device Description
The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation: restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium. components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillae, mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
The RDS TPS Dental Implant System has been tested to ensure that all design specifications have been met. Dimensional inspections are routinely performed, Specifications have boom new Billions strength, Electrochemical Corrosion Evaluation Abrasion testing to oneoro TF & Soung East and Restorative Alloys has been performed to or oncoupled and Outplou implain a exposed to artificial saliva and to determine the Gelemine Corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Tigalvanic couples, and the Mechanical Properties of the Plasma Spray Coating have been analyzed. All have been found to be within acceptable limits.
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
JUL 1 4 1999
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
Carolyn Anderson Ph: 612-368-6324 Fax: 612-368-4278.
2. General Information
| Trade Name | Single Stage Implant, TPS, 4.1mm, 1.8mm Collar (RDS) Single Stage Implant, TPS, 4.1mm, 2.8mm Collar (RDS) Single Stage Implant, TPS, 4.8mm, 1.8mm Collar (RDS) Single Stage Implant, TPS, 4.8mm, 2.8mm Collar (RDS) Indexed Abutment System (RDS) COC Abutment System (RDS) O-Ring Abutment System (RDS) |
|---|---|
| Common / Usual Name | Single Stage Dental Implant |
| Classification Name | Endosseous Implant |
| Identification of Equivalent Devices | ITI 4.1mm Solid Screw Implant and Accessories (K894595, K920768), manufactured by Straumann Dental, and |
| Restore Self-Tapping Implant System (K 924589), manufactured by Lifecore Biomedical, Inc. |
3. Device Description
The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation:
restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those
surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium.
components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.
4. Intended Use
- "Intended Goo Elleoore o Bingle Clagibles and maxillae in the following areas:
1
- Support of fixed (cement retained) restorations utilizing abutment options. .
- Support of fixed (cement retained) roctoriations attitling multiple abutment . options.
- options:
Overdenture retention by means of an o-ring or bar appliance. . - Terminal or intermediate abutment support for fixed bridgework. .
- r ommal of intermediations without involvement of adjacent dentition when the . locking taper is engaged.
| Feature | Subject Device | Predicate Devices | |
|---|---|---|---|
| Intended Use | Lifecore Regular | ||
| Diameter Single | |||
| Stage (RDS) TPS | |||
| Dental Implant | ITI 4.1 mm Solid | ||
| Screw Implant | |||
| (K894595, K920768) | Restore Self-Tapping | ||
| Implant (K924589) | |||
| Identical to | |||
| predicate devices | Surgical placement in | ||
| maxillary and/or | |||
| mandibular arch to | |||
| support crowns, | |||
| bridges, overdentures | |||
| in edentulous or | |||
| partially edentulous | |||
| patients | Indicated for single | ||
| edentulous spaces, | |||
| large edentulous | |||
| segments between | |||
| teeth, unilateral and | |||
| bilateral free-end | |||
| saddle areas, and the | |||
| totally edentulous | |||
| mandibles and | |||
| maxillae. | |||
| Material: | CP Titanium | ||
| (Grade 4) | CP Titanium (Grade |
-
| CP Titanium (Grade -
|
| Design | | | |
| External screw
threads | YES | YES | YES |
| Implant Body
Diameter (mm) | 4.1, 4.8 | 4.1, 4.8 | 3.75, 4.0 |
| Shoulder
Diameter (mm) | 4.8 | 4.8 | 4.089 |
| Collar Height
(mm) | 1.8, 2.8 | 1.8, 2.8 | 0.81 |
| Lengths | 8.0, 10.0, 12.0,
14.0, 16.0 | 8.0, 10.0, 12.0, 14.0,
16.0 | 8.0, 10.0, 11.5, 13.0,
15.0, 18.0 |
| One stage | YES | YES | NO |
| Implant/abutment
interface | Locking Taper | Locking Taper | External Hex |
| Cutting Flute | YES | NO | YES |
| TPS Coating | YES | YES | YES |
| Gamma sterilized | YES | YES | YES |
| Attachments | | | |
| Screw-retained
restoration
system | YES (Indexed
Abutment
System) | YES (Octasystem®) | YES (ONE System
Abutment, UCLA
Abutment System) |
| Cemented
restoration
system | YES (RDS COC
Abutment
System) | YES (Solid Abutment
System) | YES (COC Abutment
System) |
| Overdenture
restoration
system | YES (RDS O-
Ring Abutment
System) | YES (Retentive
Anchor System) | YES (Dalla Bona and
O-Ring Abutment
Systems) |
| Instruments
(surgical and
restorative) | YES | YES | YES |
5. Technological Characteristic Comparisons
2
6. Nonclinical Tests
The RDS TPS Dental Implant System has been tested to ensure that all design specifications have been met. Dimensional inspections are routinely performed, Specifications have boom new Billions strength, Electrochemical Corrosion Evaluation Abrasion testing to oneoro TF & Soung East and Restorative Alloys has been performed to or oncoupled and Outplou implain a exposed to artificial saliva and to determine the Gelemine Corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Tigalvanic couples, and the Mechanical Properties of the Plasma Spray Coating have been analyzed. All have been found to be within acceptable limits.
7. Substantial Equivalence Comparison
The RDS TPS Dental Implant System is substantially equivalent to the following products:
| TI 4.1 mm Solid Screw Implant
and Accessories | Restore Self-tapping Implant
System |
|------------------------------------------------------------|-------------------------------------------------------------------|
| Institut Straumann AG
CH-4437 Waldenburg
Switzerland | Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska, MN 55318 |
| Premarket Notification
Number: K894595, K920768 | Premarket Notification Number:
K924589 |
8. Conclusion (statement of equivalence)
The data submitted in this 510(k) is in support of substantial equivalency of the Lifecore Regular Diameter Single Stage (RDS) TPS Dental Implant System to the following commercially marketed devices:
These current products as defined by their product literature, demonstrate the basis for the substantial equivalency relative to indications, materials, design, and surface characteristics. The intended use of these devices is the same as the Lifecore RDS TPS Dental Implant System. The comparative analysis demonstrates the substantial equivalence of the Lifecore RDS TPS Dental Implant System to the predicate devices that are in commercial distribution.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1999
Ms. Carolyn Anderson Regulatory Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318
Re : K991114 Trade Name: Regular Diameter Single Stage (RDS) TPS Dental Implant System Regulatory Class: III Product Code: DZE March 31, 1999 Dated: Received: April 1, 1999
Dear Ms. Anderson:
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, 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 poriodic 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.
4
Page 2 - Ms. Anderson
Please note: this response to your premarket notification Please note: this response to your premarkne might have under
submission does not affect any obligation you might have under submission does not after any one for devices under the sections 531 through 342 or the not spoorsions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as the FDA This letter will allow you co began and fification. The FDA described in your 510(K) prematic normalence of your device to a legally
finding of substantial equivalence of acclacitication for your finding of substantial equivalence of yolassification for your marketed predicate device results in a crabbilities. The market.
If you desire specific advice for your device on our labeling If you desire specific advice tor yourselves and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Farc ove and services), please contact the Office of yitro diagnostic devices), prease conomaly, for questions on Compliance at (301) 334-4622. Addressed in please contact
the promotion and advertising of your device, please no the promotion and advertusing or your acsaces promotion of complease note the Office of Compliance at (301) 534 1039 feesence to Other general Che regulacion encribed (21 CFR 807 97). premation on your responsibilities under the Act may be information on your responsiblically Manufacturers Assistance obtained from the Division of Smart Hanar Handre (301) 443-6597 or at its to at its toll-free number (600) 636-2041 of (600) 2007
its internet address "http://www.fdf.gov/cdrh/dsmamain.html".
Sincerely yours
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
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Devilos Name:
Indications for Use:
- The Regular Diameter Single Stage TPS Dental Implant System is indicated for use . in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ (Per 21 CFR 801.109)
Susan Runny
510(k) Number