(53 days)
Not Found
No
The summary describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device, ScrewVent and Tapered ScrewVent implants, is an implantable medical device used for tooth replacement and bridgework, but its function is structural rather than therapeutic in the sense of treating a disease or disorder with active intervention beyond replacement.
No
The device, ScrewVent and Tapered ScrewVent implants, is described as a surgical implant for tooth replacement, not a device used to diagnose medical conditions.
No
The device description explicitly states that the device is a "screw type implant made from titanium alloy," indicating it is a physical hardware device, 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 a surgical implant for attachment of dental prosthetics. This is a device intended for use within the body, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a titanium alloy screw-type implant, which is consistent with a surgical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the ScrewVent and Tapered ScrewVent implants are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
Sulzer Dental's 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.
ScrewVent and Tapered ScrewVent implants have the same intended use as the predicate implants.
The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.
The overall design of the ScrewVent and Tapered ScrewVent implants are similar to the predicate implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles or maxillae
edentulous or partially edentulous mandibles or maxillae
edentulous mandible (specifically, between the mental foramina)
upper or lower jaw
maxillary and/or mandibular arches
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K992937, K993595, K984104, K002374
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.
Not Found
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).
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
Attachment 16
NOV 1 9 2001
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: | 760-929-4104 |
| Registration Number: | 2023141 |
| Contact Person: | Foster Boop |
| Date Summary Prepared: | September 26, 2001 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant |
| Device Trade Name: | ScrewVent® and Tapered ScrewVent® |
The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374).
1. Intended Use:
Sulzer Dental's 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.
ScrewVent and Tapered ScrewVent implants have the same intended use as the predicate implants.
2. Description:
ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.
3. Technological Characteristics:
There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface.
Page 1 of 2
1
4. Comparison Analysis:
The overall design of the ScrewVent and Tapered ScrewVent implants are similar to the predicate implants. See Table 1 below for a comparison of the Advent and Swiss Plus implants and the predicate devices.
| Characteristic | Branemark System | ITI Implants | ScrewVent & Tapered ScrewVent |
|---|---|---|---|
| Intended Use | Intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patients chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. | Intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. | Intended for surgical implantation 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. |
| Indication | Immediate Load | Immediate Load | Immediate Load |
| Design | Threaded, root form implant | Threaded, root form implant | Threaded, root form implant |
| Placement Method | Two or Single Stage Surgery | Single Stage Surgery | Two or Single Stage Surgery |
| Material | Commercially Pure Titanium | Commercially Pure Titanium | Titanium alloy |
| Diameter (mm) | 3.75mm and 4.0mm | 3.3mm, 4.1mm and 4.8mm | ScrewVent: 3.7mm & 4.7mm |
| Tapered ScrewVent: 3.7mm, 4.7mm & 6.0mm | |||
| Lengths | 10mm – 18mm | 8mm – 16mm | 8mm – 16mm |
| Implant Surface | Machined | ||
| Roughened - TiUnite | TPS coated | ||
| Roughened - Sandblasted | |||
| Largegrit Acid washed (SLA) | HA coated/Roughened | ||
| or | |||
| Roughened - HA blasted | |||
| Packaging | Glass ampoule in peel-open blister pack | Ampoule | Double vial system |
| Sterilization | Dry heat | Gamma irradiation | Gamma irradiation |
Table 1: Summary of Comparison
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2001
Mr. Foster Boop Manager, Submissions & Complaints Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K013227
Trade/Device Name: Screw Vent Implant; Tapered Screw Vent Implant Regulation Number:872.3640 Regulation Name: Dental Implant or Endosseous Implant Regulatory Class: III Product Code: DZE Dated: September26, 2001 Received: September 27, 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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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
NOV 1 9 2001
KOi3227
10(K) Number (if known): K013227د
Device Name: ScrewVent Dental Implant
Indications for Use:
The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Suan Runner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use_
(Optional Format 1-2-96)