(29 days)
ZOP30S13, ZOP37S13
Not Found
No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant (dental implant) intended for the support and retention of dental restorations, which implies a therapeutic purpose to restore dental function and aesthetics.
No
This device is a dental implant used for supporting and retaining fixed restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a physical dental implant made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a dental implant designed to be surgically placed in the jawbone to support dental restorations. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes. Its function is purely structural and restorative.
N/A
Intended Use / Indications for Use
Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Product codes
DZE
Device Description
The Zimmer One-Piece Implant, 4.7mm, Straight is a one-piece endosseous dental implant which is a combination of implant and abut pent sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface are for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
premolar, cuspid, and incisor regions of partially edentulous jaws; anterior mandibular arch
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
The Zimmer® One-Piece, 4.7mm, Straight implant is substantially equivalent to the Zimmer® One-Piece 3.0mm & 3.7mm, Straight implants as evidenced in mechanical testing.
Key Metrics
Not Found
Predicate Device(s)
Zimmer® One-Piece Implant, 3.0mm, Straight (cat. no. ZOP30S13), Zimmer® One-Piece Implant, 3.7mm, Straight (cat. no. ZOP37S13)
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
Image /page/0/Picture/0 description: The image shows a logo with the letter 'Z' inside a circle. Below the circle, the word 'zimmer' is written in a stylized font. Underneath 'zimmer', the word 'dental' is written in a smaller, less distinct font.
| Zimmer Dental |
|---|
| --------------- |
KO62281 510k No.:
Page No .: 12.7-1
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
SEP - 5 2006
Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | August 3, 2006 |
-
- Device Name: Zimmer® One-Piece Implant, 4.7mm, Straight
Device Classification Name: Endosseous Dental Implant
- Device Name: Zimmer® One-Piece Implant, 4.7mm, Straight
-
ന് Predicate Device(s): Zimmer® One-Piece Implant, 3.0mm, Straight (cat. no. ZOP30S13) Zimmer® One-Piece Implant, 3.7mm, Straight (cat. no. ZOP37S13)
4. Device Description:
The Zimmer One-Piece Implant, 4.7mm, Straight is a one-piece endosseous dental implant which is a combination of implant and abut pent sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface are for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.
-
- Intended Use:
Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- Intended Use:
1
Zimmer® One-Piece, 4.7mm, Straight; 510(k) Summary cont'd;
6. Device Comparison:
The Zimmer® One-Piece, 4.7mm, Straight implant is substantially equivalent to the Zimmer® One-Piece 3.0mm & 3.7mm, Straight implants as evidenced in mechanical testing. The Zimmer® One-Piece Implant, 4.7mm, Straight is substantially equivalent to the Zimmer® One-Piece, 3.0mm & 3.7mm, It raight implants in that it is manufactured from one piece of titanium with the abutnent and implant portions combined. The new device is a dimensional modification. The materials, general structure, and function in the endosseous implant system remains the same as the 3.0 & 3.7mm, straight one-piece predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2006
Ms. Erin McVey Senior Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K062281
Trade/Device Name: Zimmer® One Piece Implant, 4.7mm, Straight Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 4, 2006 Received: August 7, 2006
Dear Ms. McVey:
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.
3
,
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.
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Qur
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ Ko622281
Device Name: Zimmer® One-Piece Implant, 4.7mm, Straight
Indications For Use:
ﺎ، ﻣ
Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Prescription Use X (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)
Susan Rumpe
Sign-Off) (Concion Sign-Off)
Dision of Anesthesiology, General Hospital,
Division Oratral, Dental Devices Disision of Anesthesiones
510(k) Number:__
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