(24 days)
No
The 510(k) summary describes a physical dental device (healing cap) and makes no mention of AI or ML technology.
No.
The device is a temporary cap used for protection and as a base for a temporary crown, rather than directly treating a disease or condition.
No
The device is described as a "Temporary/Healing Cap" placed after surgery to protect an abutment and facilitate soft tissue healing, or as a base for a temporary crown. Its purpose is protective and restorative, not diagnostic.
No
The device description clearly states it is a "cap" which is a physical object, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a dental abutment during soft tissue healing and serve as a base for a temporary crown. This is a mechanical function within the body.
- Device Description: The description details a physical cap placed over a dental component.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a physical component used in a dental procedure.
N/A
Intended Use / Indications for Use
The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.
Product codes
NHA
Device Description
The Stage-1 Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.
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)
K991114, K994205, K003226, K051614
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Healing/Temporary Cap
JAN 2 3 2006
510(K) SUMMARY [As required by 21 CFR 807.92(c)]
1. Submitter's Name and Contact Person
| Lifecore Biomedical, Inc.
3515 Lyman Blvd
Chaska, MN 55318 | Brian Smekal
Regulatory Affairs Specialist
Ph: 952-368-6306; Fax: 952-368-4278 |
| ------------------------------------------------------------------ | -------------------------------------------------------------------------------------- |
|---|
2. General Information
| Trade Name | Stage-1® Temporary/Healing Cap |
|---|---|
| Common Name | Healing Abutment Cap, Temporary Cap |
| Classification Name | Endosseous Implant Abutment |
| Identification of Predicate Devices | Stage-1® Cement-On Crown |
| (COC) Abutment Healing Cap | |
| (K991114, K994205 and | |
| K003226) PrimaConnex™ Quick-Abutment | |
| Temporary/Healing Cap | |
| (K051614) |
3. Device Description
The Stage-1 ** Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.
4. Intended Use
The Stage-1 * Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alonc or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.
1
Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Healing/Temporary Cap
5. Substantial Equivalence Comparison
Summary of how the new Stage-1® Temporary/Healing Cap is substantially equivalent to the Stage-1® COC Abutment Healing Cap:
- Have the same intended use. .
- Incorporate the same basic healing cap design, .
- Have the same shelf life, and .
- Are packaged and sterilized using the same materials and processes. .
Summary of how the new Stage-1® Temporary/Healing Cap is substantially equivalent to the PrimaConnex™ Quick-Abutment TemporaryHealing('); }); }); }); } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }
- Have the same intended use. .
- Incorporate the same basic healing cap design, .
- Incorporate the same biocompatible materials, .
- . Have the same shelf life.
- And are packaged and sterilized using the same matcrials and processes. t
In summary, the Stage-1* Temporary/Healing Cap described in this submission is, in our opinion, substantially equivalent to the predicate devices.
్రా 20 +
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2006
Lifecore Biomedical, Incorporated Mr. Brian Smekal Regulatory Affairs Specialist Oral Restorative Division 3515 Lyman Boulevard Chaska, Minnesota 55318-3051
Re: K053643
Trade/Device Name: Stage-1® Temporary/Healing Cap-Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 29, 2005 Received: December 30, 2005
Dear Mr. Smekal:
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 - Mr. Smekal
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 (OS) 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 (301) 443-6597 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
Lifecore Biomedical, Inc. Special 510(k) Premarket Notification Stage-1® Temporary/Healing Cap
Indications for Use Statement
510(k) Number (if known):
Device Name: Stage-1® Temporary/Healing Cap
Indications for Use:
The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suse, Rünne
Mary General Hosp
Control, Dental Devices
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