(81 days)
ZOP37S13, SVMB13, ZOA342A
Not Found
No
The 510(k) summary describes a mechanical dental implant and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a dental implant used for fixed single tooth and fixed partial denture restorations, which is a restorative rather than a therapeutic function.
No
Explanation: The device description and intended use clearly state that this is a dental implant used for the support and retention of fixed single tooth and fixed partial denture restorations. It is a physical device implanted into the jaw, not a tool used to diagnose conditions or diseases.
No
The device description clearly states it is a physical dental implant made of titanium alloy, not software.
Based on the provided information, 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 description clearly states that this is a dental implant designed to be surgically placed in the jawbone to support dental restorations. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Zimmer® One-Piece 3.7mm, Angled implant is a surgical dental device, not an IVD.
N/A
Intended Use / Indications for Use
Zimmer® One-Piece 3.7mm 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 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece 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, 3.7mm, Angled is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion is angled by 17 degrees. 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 area 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.
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, 3.7mm, Angled implant is substantially equivalent to the Zimmer® Screw Vent® Mini™/ Contour Hex-Lock™ Abutment, 3.5mm. Angled assembly as evidenced in mechanical testing.
Key Metrics
Not Found
Predicate Device(s)
Zimmer® One-Piece Implant, 3.7mm, Straight (cat. no. ZOP37S13), Zimmer® Screw Vent® Mini™ 3.7mm (cat. no. SVMB13) + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm (cat. no. ZOA342A)
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 the logo for Zimmer Dental. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font. Below the word "zimmer", the word "dental" is written in a smaller, sans-serif font.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No.: K061717
Page No.: 12.7-1
SEP - 8 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: | June 16, 2006 |
-
- Device Name: Zimmer® One-Piece Implant. 3.7mm. Angled
Device Classification Name: Endosseous Dental Implant
- Device Name: Zimmer® One-Piece Implant. 3.7mm. Angled
-
- Predicate Device(s): Zimmer® One-Piece Implant, 3.7mm, Straight (cat. no. ZOP37S13) Zimmer® Screw Vent® Mini™ 3.7mm (cat. no. SVMB13) + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm (cat. no. ZOA342A)
4. Device Description:
The Zimmer One-Piece Implant, 3.7mm, Angled is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion is angled by 17 degrees. 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 area 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 3.7mm 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 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- Intended Use:
1
12.7-2
Zimmer® One-Piece, 3.7mm, Angled; 510(k) Summary cont'd:
ି. Device Comparison:
The Zimmer® One-Piece, 3.7mm, Angled implant is substantially equivalent to the Zimmer® Screw Vent® Mini™/ Contour Hex-Lock™ Abutment, 3.5mm. Angled assembly as evidenced in mechanical testing. The Zimmer © One-Piece Implant, 3.7mm, Angled is substantially equivalent to the Zimmer® One-Piece, 3.7mm, Straight implant in that it is manufactured from one piece of titanium with the abutment and implant portions combined. The 3.7mm, angled one-piece implant is identical in design as the 3.7mm, straight implant except the abutment portion is angled by 17 degrees. The new device is a dimensional modification. The materials, general structure, and function in the endosseous implant system. remains the same as the 3.7mm, straight one-piece predicate de inp.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Erin McVey Senior Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
SEP = 8 2006
Re: K061717
Trade/Device Name: Zimmer® One-Piece Implant, 3.7mm, Angled Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 27, 2006 Received: August 8, 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
Page 2 - Ms. McVey
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 yours,
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): ך 7 7 7 7 1 1 6 ט
Device Name: Zimmer® One-Piece Implant, 3.7mm, Angled
Indications For Use:
Zimmer® One-Piece 3.7mm, Angled 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 3.7mm, Angled implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 3.7mm, Angled 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)
on Sign-Cif) on of Anesthesiology, General Hospital, Control, Dental Devices
Number. K 061711
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