(29 days)
The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.
The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.
The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional coping is not to exceed 28 days.
The new abutments have a prepared margin and cone shape. A prepared margin and cone shape top portion and an apex with a hex configuration with 1 degree tapered flats. . The taper on the cone of the abutment is 3 degrees. The cone of the abutment has a flat section for anti-rotation.
The Healing Cap is made to precisely fit the abutment for placement on the Abutment at the time of placement to protect the soft tissue during the healing process.
The provisional coping is made to precisely fit the abutments to allow for the placement of a provision crown on the abutment.
This document is a 510(k) Pre-Market Notification for a medical device (Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary (pages 0-1) describes:
- Submitter's Information: Zimmer Dental Inc.
- Device Name: Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping
- Device Classification Name: Endosseous Dental Implant Abutment
- Predicate Device(s): Zimmer® Dental 3.5mm Hex-Lock Abutment (HLA3/3), Zimmer® Contour Healing Cap, Zimmer Contour Provisional Coping.
- Device Description: The new abutments have a prepared margin and cone shape, a hex configuration with 1-degree tapered flats, and a 3-degree cone taper with a flat section for anti-rotation. The healing cap and provisional coping are designed to precisely fit the abutments.
- Intended Use: (page 1)
- Hex-Lock Short Abutment: Terminal or intermediate abutment for a cemented prosthesis (single or multiple-unit restoration).
- Short Healing Cap: Used with the Short Hex-Lock Abutment to prevent soft tissue irritation and material lodging during healing.
- Short Provisional Coping: Used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment, not to exceed 28 days of use.
- Device Comparison: (page 1) The new devices are described as "equivalent in design with Predicates" and "dimensional modifications" (shorter in overall height) to previously cleared devices. Materials, general structure, and function remain the same.
The FDA letter (pages 2-3) confirms the clearance of the device based on substantial equivalence to predicate devices, subject to general controls and applicable specific controls.
The "Indications for Use" form (page 4) reiterates the intended uses as described above.
Therefore, based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. This type of information (specific performance data, acceptance criteria, details of a clinical or non-clinical study) is typically found in the full 510(k) submission, not necessarily in the publicly available 510(k) summary or determination letter. The document explicitly states this is a "Special 510(k): Device Modification" and relies on substantial equivalence to predicate devices, implying that extensive new performance studies with acceptance criteria might not have been required beyond demonstrating that the modifications do not raise new questions of safety or effectiveness.
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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 stylized letter Z inside. Below the circle, the word "zimmer" is written in a bold, sans-serif font, with a line underneath it. Below "zimmer", the word "dental" is written in a smaller, cursive font.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No .:
Attachment 12.8 1 of 2
Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k) APR - 7 2009
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
Name: Zimmer Dental Inc. Address: Zimmer 1900 Aston Ave. dental Carlsbad, CA 92008 Phone: 760-929-4300 Contact: William Fisher Date Prepared: March 4, 2009
- Submitter's Information:
- Device Name: Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping (cat no. SA341, SA342, SA451, SA452, SA561, SA562, SAHEAL4, SAHEAL5, SAHEAL6, SAPROV4, SAPROV5, SAPROV6)
Device Classification Name: Endosseous Dental Implant Abutment
- Predicate Device(s): Zimmer® Dental 3.5mm Hex-Lock Abutment (HLA3/3) 3. Zimmer® Contour Healing Cap (e.g.: ZOCHEAL4S) Zimmer Contour Provisional Coping (e.g. ZOCPROV4S)
-
- Device Description:
The new abutments have a prepared margin and cone shape. A prepared margin and cone shape top portion and an apex with a hex configuration with 1 degree tapered flats. . The taper on the cone of the abutment is 3 degrees. The cone of the abutment has a flat section for anti-rotation.
The Healing Cap is made to precisely fit the abutment for placement on the Abutment at the time of placement to protect the soft tissue during the healing process.
The provisional coping is made to precisely fit the abutments to allow for the placement of a provision crown on the abutment.
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Attachment 12.8 2 of 2
ട. Intended Use:
్రామ
The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.
The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.
The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional cap is not to exceed 28 days.
6. Device Comparison:
The new devices are equivalent in design with Predicates. The new devices are dimensional modifications to the Predicates cleared in K953101 and K061043. They differs from the Predicate in that they are shorter in overall height. The materials, general structure, and function in the endosseous implant system remains the same as the Predicate Devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Fisher Regulatory Affairs Associate Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008
APR - 7 2009
Re: K090723
Trade/Device Name: Hex-Lock Short Abutment, Short Healing Cap. Short Provisional Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 4, 2009 Received: March 9, 2009
Dear Mr. Fisher:
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.
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Page 2 - Mr. Fisher
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Shule H. Murphy, MD for Susan Rummer DDS
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Zimmer Dental Inc.Hex-Lock Short Abutment | 510(k) No. | Attachment 12.131 of 1 | ||
|---|---|---|---|---|
| Indications for Use | ||||
| 510(k) Number (if known): | ||||
| Device Name: Hex-Lock Short Abutment,Short Healing Cap,Short Provisional Coping | ||||
| Indications For Use: | ||||
| multiple-unit restoration. | The Hex-Lock Short Abutment is used as a terminal or intermediateabutment for a cemented prosthesis. It can be used for a single or | |||
| any undercuts or openings. | The Short Healing Cap is for use with a Short Hex-Lock Abutment toprevent irritation of soft tissue due to rubbing against the restorativearea of the abutment or implant, and to prevent material from lodging in | |||
| provisional coping is not to exceed 28 days. | The Short Provisional Coping is used for fabricating a cement-retainedprovisional restoration for a Short Hex-Lock Abutment. Use of the | |||
| Prescription Use(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) | |
| NEEDED) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF | |||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
| (Division Sign-Off) | Division of Anesthesiology, General Hospital |
Infection Control, Dental Devices
510(k) Number: K090723
§ 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.)