(80 days)
Not Found
No
The summary describes dental filling materials and bonding agents, with no mention of AI or ML capabilities or related performance metrics.
No.
The device is a dental filling material, which is a restorative material used for dental procedures, not a therapeutic device.
No
The devices described are filling materials and bonding agents used for dental restorations, not for diagnosing medical conditions. Their indications explicitly state "dental filling of cavities" and similar restorative uses.
No
The device description clearly outlines physical components (bonding agent, composite, compomer) which are materials used for dental fillings, 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 for "dental filling of cavities," "filling of all classes of cavities," "Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth," and "all adhesive restorations with compomers and composites." These are all procedures performed directly on the patient's teeth for restorative purposes.
- Device Description: The device description details materials used for filling and bonding teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for treatment and restoration.
N/A
Intended Use / Indications for Use
The SternOmega Dental Composite System is indicated for dental filling of cavities.
The SternOmega Composite LC is indicated for filling of all classes of cavities:
The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.
The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
Product codes
EBF
Device Description
The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.
The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.
The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.
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
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.
Key Metrics
Not Found
Predicate Device(s)
K962348, K940513, K964773, K973388, K844662, K963805, K921820, K932013, K964285, K922569, K951836, K950991, K962442
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
K 98 X612
OCT 22 1998
510(k) Summary
| Trade Name: | SternOmega Dental Composite System consisting of SternOmega Bonding
Agent, SternOmega Composite LC and SternOmega Compomer LC |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Sterngold ImplaMed
23 Frank Mossberg Drive
P.O. Box 2967
Attleboro, MA 02703-0967
Registration #2921595 |
| Device Generic Name: | Dental composite system |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
Predicate Devices:
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| SternOmega Bonding Agent | ||
| Prime & Bond 2.1 | K962348 | Dentsply Int'l. |
| Optibond Solo Single Component | K940513 | Kerr Mfg. Co. |
| Dentemp One Step | K964773 | Bisco (Majestic Drug Co.) |
| Bond 1 | K973388 | Jeneric/Pentron Inc. |
| Single Bond | Unknown | 3M |
| SternOmega Composite LC | ||
| XRV Herculite | K844662 | Kerr Mfg. Co. |
| Prodigy AC | K963805 | Sybron Dental Specialties |
| Renamel Hybrid | K921820 | Cosmedent, Inc. |
| Charisma | K932013 | Heraeus Kulzer |
| Tetric Ceram | K964285 | Ivoclar North America |
| Tetric | K922569 | Ivoclar North America |
| SternOmega Compomer LC | ||
| Compoglass | K951836 | Ivoclar North America |
| Dyract | K950991 | Dentsply Int'l. |
| Hytac Aplitip | K962442 | ESPE |
Product Description:
The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.
The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.
The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.
0 - 65,73
1
Indications for Use:
The SternOmega Dental Composite System is indicated for dental filling of cavities.
The SternOmega Composite LC is indicated for filling of all classes of cavities.
The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.
The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
Safety and Performance:
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Omega Dental Composite System has been shown to be safe and effective for its intended use.
C: 6: 1
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The bird is positioned diagonally within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1998
Sterngold ImplaMed C/O Ms. Pamela Papineau Delphi Medical Device Consultant 50 Brewster Street Pawtucket, Rhode Island 02860
K982692 Re: SternOmega Bonding Agent, SternOmega Trade Name: Composite LC, SternOmega Compomer LC II Requlatory Class: Product Code: EBF July 27, 1998 Dated: August 3, 1998 Received:
Dear Ms. Papineau:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. বৈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Papineau
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041; or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): _
Device Name: SternOmega Dental Composite System consisting of : SternOmega Bonding Agent, SternOmega Composite LC and SternOmega Compomer LC
Indications for Use:
The SternOmega Dental Composite System is indicated for dental filling of cavities.
The SternOmega Composite LC is indicated for filling of all classes of cavities:
The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.
The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hevell Sheppes
(Division Sign-Off)
Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use
C30014