(66 days)
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No
The document describes a dental implant system made of titanium alloy with specific dimensions and features. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies sections.
No
The device is a dental implant system used for structural replacement of teeth or for attaching prostheses, not to treat or cure a disease or condition.
No
Explanation: The provided text describes dental implants used for tooth replacement and as anchors for prostheses. This is a therapeutic or restorative device, not one that identifies or diagnoses a condition or disease.
No
The device description explicitly states that the device is fabricated from titanium alloy and is provided sterile, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dental implant system for surgical placement in the jawbone to support dental prostheses. This is a surgical device used in vivo (within the body).
- Device Description: The description details the physical characteristics of the implant, such as material, size, and surface treatment. This aligns with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant system does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Small Diameter Spline Twist implant is identical to the intended use of the predicate implants. Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
Sulzer Dental recommends the Small Diameter Spline Twist implant for use in the Suizer Dental recomment the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.
Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would use of the 5.0mm implant larger than 4.0mm. The 3.15mm implant is recommended diciale the asc or an implant surger axillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.
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
edentulous mandibles or maxillae, maxillary laterals
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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 = 6 2001
1012055
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.
| Company Name: | Sulzer Dental Inc. |
|---|---|
| Address: | 1900 Aston Avenue, Carlsbad, CA 92008-7308 |
| Telephone Number: | 760-431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Foster Boop |
| Date Summary Prepared: | September 5, 2001 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant |
| Device Trade Name: | 3.15mm Spline Twist |
The primary device used for comparison in this summary is Sulzer Dental's existing Spline Cylinder and Spline Twist implants. All implant systems are manufactured in the same facility located in Carlsbad, California.
1. Intended Use:
The intended use of the Small Diameter Spline Twist implant is identical to the intended use of the predicate implants. Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
Sulzer Dental recommends the Small Diameter Spline Twist implant for use in the Suizer Dental recomment the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.
2. Description:
Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.
3. Technological Characteristics:
The Spline Dental Implant line has been modified to include a 3.15mm diameter The threaded design includes self-tapping capabilities. The threaded implant. implantabutiment interface remains unchanged. There has been no change to the implant materials or to the implant/abutment interface.
Page 1 of 2
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4. Comparison Analysis:
The overall design of the Spline Twist implant is similar to the predicate implant. The Overal debigin of a comparison of the Spline Twist implant and the predicate device.
| Feature | Small Diameter Spline Twist Implant | Predicate Device K944327 & K946311 | Predicate Device K962106 |
|---|---|---|---|
| Implant body geometry | Tapered, Self-Tapping Screw | Cylinder | Self-Tapping Screw Type |
| Implant Lengths | 10, 11.5, 13, 15 & 18mm | 8, 10, 13, 15 & 18mm | 8, 10, 13, 15 & 18mm |
| Implant Body Diameter | 3.15mm | 3.25mm | 3.75mm & 5.0mm |
| Implant Material | Titanium alloy | Same | Same |
| Implant Surface | Roughened | HA coated | |
| TPS coated | Roughened | ||
| Implant/Abutment Interface | Spline tine anti-rotational interface | Same | Same |
| Abutment Options | Fixed, Preangled, Shouldered, Overdenture & Gold copings | Same | Same |
| Manufacturing Site | Carlsbad, CA. | Same | Same |
| Packaging | Vial inside PETG tray sealed with Tyvek lid | Same | Same |
| Sterile | Yes | Yes | Yes |
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three heads, depicted in a simple, black line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Mr. Foster Boop Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K012055
Trade/Device Name: 3.25mm Spline Twist Implant Regulation Number: 21 CFR 872.3640 Regulation Name: D Dental Implant Regulatory Class: Class III Product Code: DZE Dated: June 29, 2001 Received: July 2, 2001
Dear Mr. Boop:
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.
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.
3
Page 2 - Mr. Boop
This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to ocelli manetang your seubstantial equivalence of your device to 510(K) premarket nonition. "The ID: 14 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 IT you desire specific ad rice to: your for in vitro diagnostic devices), please contact the allu additionally 27 CLN Part 609110 103. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promot Office of Comphance at (301) 89 : "The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, produce in to regul 807.97). Other general information on your responsibilities under notification (21GFF Part 601197). Villion of Small Manufacturers, International and the Act may be obtained from the Briumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): _ K012055
Device Name: 3.15mm Spline Twist Implant
Indications for Use:
Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae Suizer Denal informati Bysteins the prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would use of the 5.0mm implant larger than 4.0mm. The 3.15mm implant is recommended diciale the asc or an implant surger axillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| | Over-The-Counter-Use
(Optional Format 1-2-96) |
|---------------------------------------------------------------------|--------------------------------------------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K02055 |
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