(70 days)
No
The document describes a dental implant and its physical characteristics and intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is designed for use in the body to replace missing teeth and provide support for dental prostheses, which is a therapeutic function.
No.
The device is described as a dental implant system designed for prostheses attachment and tooth replacement, which are therapeutic and restorative functions, not diagnostic.
No
The device description clearly details a physical dental implant made of titanium alloy with a hydroxylapatite coating, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system designed 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 a dental implant, including its material, design, and coating. 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 (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant does not fit that description.
N/A
Intended Use / Indications for Use
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw type endosseous dental implant design for bone level placement and can be used in a single or two stage protocol. Refer to Figure 1, product renderings. The implant will have a straight body with an external single lead thread design. The new device implant body, fabricated from 6Al-4V titanium alloy, features single lead threads that begin 0.75mm apical of the base of the implant Spline tines and continue to the apex of the implant. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake andle to the osteotomy in a manner similar to a spiral flute thread tap. It has a Spline interface that consists of six tines. These tines interdigitate with like tines on abutments used in the system to create an anti-rotation interface. The new device will feature hydroxylapatite (HA) coating , hydroxylapatite coating with additional Zimmer Dental MP-1® processing equivalent to existing Zimmer Dental implants (K953101, K011028, K013227, K061410, K072589).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles or maxillae
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
§ 872.3640 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.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a bold letter "Z" inside. Below the circle, the word "zimmer" is written in lowercase letters, and below that, the word "dental" is written in smaller lowercase letters.
Zimmer Dental
10093164
510k No.:___
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
A5-1 Page No .: __
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
Zimmer Dental Inc. Name:
- Submitter's Information:
DEC 1 5 2000
Address: 1900 Aston Ave. Carlsbad, CA 92008
760-929-4300 Phone:
Melissa Burbage Contact:
Date Prepared: December 10, 2009
- 3.25mm Spline® Twist™ Implant, HA Coated 2. Device Name: (cat. No 2130, 2131, 2133, 2135)
Device Classification Name: Endosseous Dental Implant
3. Predicate Device(s):
Predicate Device #1
Trade Name:
510(k) Number: Classification: Classification Name: Classification Panel: Product Code:
Integral VI Biointegrated Dental Implant System K944327 DZE Endosseous Dental Implant Dental Implants: 1850, 1851, 1852, 1853, 1854, 1870, 1871, 1872, 1873, 1874
Predicate Device #2
Trade Name: 510(k) Number: Classification:
Small Diameter Spline Twist Implant K012055 DZE
1
3.25mm Spline® Twist™ Implant, HA Coated
510k No.:
Page No.: ____________________________________________________________________________________________________________________________________________________________________ A5-2
| Classification Name: | Endosseous Dental Implant |
|---|---|
| Classification Panel: | Dental |
| Product Code: | Implants: No finished good part numbers as the devices were never commercially distributed. |
adicate Process### Predicate Process
| Trade Name: | Calcitek HA-Coated Endosseous Dental
Implants |
|-----------------------|--------------------------------------------------|
| 510(k) Number: | K960021 |
| Classification: | DZE |
| Classification Name: | Endosseous Dental Implant |
| Classification Panel: | Dental |
4. Device Description:
The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw type endosseous dental implant design for bone level placement and can be used in a single or two stage protocol. Refer to Figure 1, product renderings. The implant will have a straight body with an external single lead thread design. The new device implant body, fabricated from 6Al-4V titanium alloy, features single lead threads that begin 0.75mm apical of the base of the implant Spline tines and continue to the apex of the implant. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake andle to the osteotomy in a manner similar to a spiral flute thread tap. It has a Spline interface that consists of six tines. These tines interdigitate with like tines on abutments used in the system to create an anti-rotation interface. The new device will feature hydroxylapatite (HA) coating , hydroxylapatite coating with additional Zimmer Dental MP-1® processing equivalent to existing Zimmer Dental implants (K953101, K011028, K013227, K061410, K072589),
5. . Indications for Use
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.
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3.25mm Spline® Twist™ Implant, HA Coated
510k No .:
Page No.: A5-3
6. Device Comparison:
The new device is substantially equivalent to the predicate devices. The device's, general structure, and function in the endosseous implant system remains the same as the predicate devices.
The 3.25mm Spline Twist Implant, HA Coated is similar in design to the previously cleared Small Diameter Spline Twist Implant. It features a Spline interface that consists of six 0.040 (1mm) tall projections called tines that are arranged circumferentially around a 1-72 unified series, thread tolerance class 3, internal thread. These tines interdigitate with like tines on abutments used on the system to create an anti-rotation interface. A threaded fastener is used to secure the abutment to the implant after assembly.
The body of the 3.25mm Spline Twist Implant. HA Coated is identical to the Small Diameter Spline Twist Implant featuring . 1240 (3.15mm) major diameter single lead threads that begin .030" (0.75mm) from the base of the implant Spline tines and continue to the apex of the implant. At a distance of . 120" (3.05 mm) coronal from the apex the major diameter of the threads begin to taper inwardly and also is interrupted by three cutting flutes spaced circumferentially at 120 degrees from one another. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake angle to the osteotomy in a manner similar to a spiral flute thread tap.
The implant body is fabricated from the same 6AL-4V titanium alloy as the Small Diameter Spline Twist Implant and the Integral VI Biointegrated Dental Implant System. The material is dual specified to ASTM B328 and ISO 5832-3. The ISO specification has stricter controls and material purity and the ASTM has higher limit of minimum strength. The 3.25mm Spline Twist Implant, HA Coated also features the same HA coating as the predicate Integral VI Biointegrated Dental Implant System. The coating is plasma sprayed on to the implant and then processed as the predicate Calcitek HA-Coated Endosseous Dental Implants using a hydro-thermal treatment (MP-1) to increase crystallinity.
The 3.25mm Spline Twist Implant, HA Coated used the same prosthetics as the predicates and these include engaging and not engaging abutments and copings manufactured from titanium alloy, gold alloy and plastic. Plastic is used only a burn out sleeve to create gold copings.
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510k No.:
Page No .:
Engaging abutment have tines that interdigitate with the implant tines. A circumferential collar attached to the abutment covers both implant and abutment tines when that abutment is seated. This collar seats on an annular ring on the implant that is positioned outwardly from the implant tines. Non-engaging abutments have a circumferential ring that is integral to the abutment but lack the interdigitating tines. All abutments are held to the implant by a threaded fastener which is either integral to the abutment body or a separate component.
The 3.25mm Spline Twist Implant, HA Coated will use surgical instruments similar to the predicates. A 2.7 mm intermediate drill is being added to the drill sequence and the taps utilized with the predicate Small Diameter Spline Twist Implant are also utilized. The tools used to drive the threaded implant into the osteotomy are also identical to those used on the predicate Small Diameter Spline Twist Implant.
A try-in is provided to check the osteotomy for parallelism and depth. A 2.3mm end can be used after the pilot drill to check angulations and a 3.0mm end is provided for use after the final drill. A band on the 3mm end allows the user to verify the depth of the site prior to surgical placement of the implant.
In the unlikely event that the spline tines are distorted during the surgical procedure, a spline recovery tool is provided to straighten the tines. Tine deformation is unlikely because a tap is provided to pre-thread the site in more dense bone.
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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Melissa Burbage Manager of Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
DEC 1 5 2009
Re: K093164
Trade/Device Name: 3.25 Spline® Twist™ Implant, HA Coated Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 10, 2009 Received: December 11, 2009
Dear Ms. Burbage:
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 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.
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Page 2- Ms. Burbage
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/6/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with the letter "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. Below "zimmer" is the word "dental" in a smaller, less bold font.
Indications for Use
16931104 510(k) Number (if known):
Device Name: 3.25 Spline® Twist™ Implant. HA Coated
Indications For Use:
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr.K. P. Mulry (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093164