(88 days)
Not Found
No
The document describes a physical dental restoration system (abutment and coping) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a dental restoration system (ceramic coping and titanium core) designed for single-unit, cement-retained restorations in anterior and premolar regions, which does not inherently qualify it as a therapeutic device.
No
The device description and intended use indicate that the Sulzer Dental Ceramic System - Spline is a restorative dental product (an abutment and coping system) for single-unit cement-retained restorations, not for diagnosing conditions.
No
The device description clearly outlines physical components (titanium Spline core, ceramic coping, titanium retaining screw) which are hardware.
No, 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 Sulzer Dental Ceramic System - Spline is a dental restoration system consisting of an abutment and a coping. It is used to create a physical restoration for a tooth.
- Intended Use: The intended use is to provide a physical restoration for anterior and premolar teeth. It does not involve testing samples from the body.
This device is a dental prosthetic/restorative device, not an IVD.
N/A
Intended Use / Indications for Use
The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.
Product codes
DZE
Device Description
The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and premolar (teeth)
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
Not Found
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
MAR 1 9 2002
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: 760-929-4300 Registration Number : 2023141 Contact Person: Sean Hariri Date Summary Prepared: December 17, 2001 Classification Name: Endosseous Dental Implant Common/Usual Name: Abutment for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-Spline
The Primary device used for comparison in this summary is the Gold Coping Abutment (K943180) and the FRIALIT®-2 CeraBase Abutment (K980630)
1. Intended Use:
The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.
2. Description:
The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.
3. Technological Characteristics:
The Ceramic System-Spline is an additional abutment design for the Spline Dental implant system. The system consists of two parts, the titanium alloy abutment and the ceramic coping. The abutment will be fixed to the implant with a titanium alloy screw. The net ceramic coping will be bonded with porcelain by the laboratory to fabricate the finalized coping. The finished restoration is then cemented to the abutment,
4. Comparison Analysis:
The abutment of the Ceramic System-Spline is similar to the Sulzer Dental Gold Coping Abutment and the FRIALIT@-2 CeraBase Abutment. The ceramic coping of the Ceramic
1
System is similar to commercial crowns used to fabricate a restoration. See Table 1 System is simmal to confinereial crown. System and the predicate systems.
and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
| Feature | Sulzer Dental
Ceramic System-
Spline | Predicate: Sulzer
Dental Gold Coping
Abutment | Predicate:
FRIALIT-2®
CeraBase
Abutment |
|----------------------------------------|----------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | Anterior Single
Unit Restoration
Cases | Anterior/Posterior
Single-Unit and
Multi-Unit
Restoration Cases | Anterior Single
Unit Restoration
Cases |
| Abutment Body
Geometry | Tapered Retentive
Wall | Straight Retentive
Wall | Straight
RetentiveWall |
| Abutment/Implant
Interface Diameter | 3.25mm, 4.0mm,
and 5.0mm | 3.25mm, 4.0mm,
and 5.0mm | 3.8mm, 4.5mm,
5.5mm, &
6.5mm |
| Abutment Cuff Flare
Dimater | 4.5mm | 4.5mm and 6.5mm | Variable |
| Abutment Body
Material | Titanium Alloy
(Ti-6A1-4V) | Gold Alloy | Pure Titanium
grade II |
| Implant/Abutment
Interface | Spline anti-
rotational interface | Spline anti-rotational
interface | Hex anti-
rotational
interface |
| Ceramic Coping
Material | Zirconia
Toughened
Alumina | N/A | Aluminum Oxide |
| Manufacturing Site | Carlsbad, CA | Carlsbad, CA | Meinnheim,
Germany |
| Packaging | PETG tray and
Tyvek® lid | PETG tray and
Tyvek® lid | Blister pack
combined w/
cardboard outer
wrap. |
| Sterile | No | No | No |
Table: 1 Summary of Comparison
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Mr. Sean Hariri Regulatory Affairs Associate Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K014214
Trade/Device Name: Sulzer Dental Ceramic System-Spline Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Hariri:
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
Page 2 - Mr. Hariri
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 and instills (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelate as 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,
Ti. A. Ulatowski
Timo 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Sulzer Dental Ceramic System-Spline______________________________________________________________________________________________________________________________
Indications for Use: The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. ase specifically for antorior and prother and should not be splinted together for multiple unit cases, partials or bridgework.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter-Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control,
General Hospital Devices
| Number | K014214 |
|---|---|
| -------- | --------- |
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