(90 days)
Not Found
No
The summary describes a dental restoration system with physical components (titanium core, ceramic coping) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
This device is for dental restoration (replacing a metal substructure with a ceramic one to improve esthetics), which is not considered a therapeutic function. Therapeutic devices are typically used for treating or alleviating a disease or condition.
No
The device is described as a system for anterior single unit restoration, replacing metal with ceramic for improved aesthetics. It is a restorative device, not one that identifies or analyzes medical conditions.
No
The device description clearly outlines physical components: a titanium hex core (abutment), a ceramic coping, and a titanium retaining screw. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for anterior single unit restoration cases, specifically for improving esthetics by replacing a metal substructure with a ceramic one. This is a restorative dental procedure, not a diagnostic test performed on samples from the human body.
- Device Description: The device components (titanium hex core, ceramic coping, retaining screw) are all used for the physical restoration of a tooth. They are not designed to analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing diagnostic information.
- Using reagents or assays.
The device is clearly intended for use in a dental setting for the physical reconstruction of a tooth, which falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sulzer Dental Ceramic System-HexLock is intended for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. 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
Not Found
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.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
MAR 2 0 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 19, 2001 Classification Name: Endosseous Dental Implant Common/Usual Name: Abutment for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-HexLock
The device used for comparison in this summary is the HexLock Abutment (K953101) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use:
The Sulzer Dental Ceramic System-HexLock is intended for anterior single unit restoration cases.
2. Description:
The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. 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-HexLock is an additional abutment design for Internal Hexagon implant systems. 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 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-HexLock is similar to the Sulzer Dental HexLock abutment and the FRIALIT@-2 CeraBase Abutment. The ceramic coping of the Ceramic System is similar to commercial crowns used to fabricate a restoration. See Table 1 below for a comparison of the Ceramic System and the predicate systems.
1
Sulzer Dental Ceramic System-HexLock
| Feature | Sulzer Dental
Ceramic System-
HexLock | Predicate: Sulzer
Dental HexLock
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 Diameters | 4.5mm | 3.5mm & 4.5mm | 3.4mm, 3.8mm,
4.5mm, 5.5mm,
& 6.5mm |
| Abutment/Implant
Diameter | 3.5mm & 4.5mm | 3.5mm & 4.5mm | 3.4mm, 3.8mm,
4.5mm, 5.5mm,
& 6.5mm |
| Abutment Body
Material | Titanium Alloy
(Ti-6Al-4V) | Titanium Alloy (Ti-
6Al-4V) | Pure Titanium
grade II |
| Implant/Abutment
Interface | Hex anti-rotational
interface | Hex 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 | Two Vial System | Blister pack
combined w/
cardboard outer
wrap. |
| Sterile | No | Yes | 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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Mr. Sean Hariri Regulatory Affairs Associate Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad. California 92008-7308
Re: K014175
Trade/Device Name: Sulzer Dental Ceramic System-Hexlock Regulation Number: 872.3640 Regulation Name: Abutment For Dental Implant System Regulatory Class: III Product Code: NHA Dated: December 19, 2001 Received: December 20, 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 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,
Susan Suarez
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):
Device Name: _Sulzer Dental Ceramic System-HexLock
Indications for Use: The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.
(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)
Suger Rung
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division oal Hospital Devices Clu > 510(k) Number