(31 days)
Not Found
No
The device description and intended use are for a dental cement, and there is no mention of AI or ML technology in the provided text.
No.
The device is a cementing material used for luting dental prosthetics and for core build-up and splinting, which are restorative and structural functions, not therapeutic.
No
The device is described as a chemical cure compomer cement and a dual cure compomer cement used for permanent luting and various other dental procedures, such as core build-up and splinting of teeth. Its function is to bond materials, not to diagnose a condition or disease.
No
The device is described as a chemical cure or dual cure compomer cement, which is a physical material used for luting. The description focuses on its composition and delivery systems (automix or handmix), not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The intended use of PermaCem and PermaCem Dual is for the permanent luting (cementing) of dental restorations (crowns, bridges, etc.) and other dental procedures directly within the patient's mouth.
- Lack of Specimen Analysis: The device description and intended use do not involve the analysis of any specimens taken from the human body. It is a material used directly on or within the patient's oral cavity.
Therefore, PermaCem and PermaCem Dual are dental materials used for restorative and prosthetic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
PermaCem is a chemical cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.
PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.
PermaCem and PermaCem Dual can also be used for:
- Luting of orthodontic anchors and brackets
- Luting of abutments for dentures
- Core build-up
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
- Repair material for resin-based provisionals
- Bite registration material
- Occlusal individualisation of plastic bite rails
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
PermaCem:
PermaCem is a chemical-curing, radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:
- Luting of orthodontic anchors and brackets
- Luting of abutments to dentures
- Core build-up material
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
- Repair material for provisionals
- Bite registration material
- Build up material for plastic bite rails (occlusal individualisation).
PermaCem Dual:
PermaCem Dual is a dual cure (chemical and/or light cure), radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of
metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:
- Core build-up material .
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
- Repair material for provisionals .
- Bite registration material
- Build up material for plastic bite rails (occlusal individualisation). .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth structures
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)
This submission is an 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), DMG USA, Inc. has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 940914, K940513, K940030, K922249, K960464, K943596, K931309, K946100, K924151
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K012316' and are written in a bold, sans-serif style. The characters are all connected and are written in black ink.
AUG 2 3 2001
| Trade Name: | PermaCem / PermaCem Dual |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Device Generic Name: | Dental luting material |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. |
Predicate Devices:
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| Advance | K 940914 | Dentsply Int'l. |
| Optibond | K940513 | Kerr Mfg. Co. |
| C&B Luting Composite | K940030 | Bisco |
| Flexi-Flow | K922249 | EDS |
| C&B Metabond | K960464 | Parkell |
| Duolink | K943596 | Bisco |
| Variolink | K931309 | Vivadent |
| Dyract Cem | Unknown | Dentsply |
| Fuji Duet (Fuji Plus) | K946100 | GC |
| Resinomer | K924151 | Bisco |
| Cement-It | Unknown | Jeneric/Pentron Inc. |
| ABC Dual Adhesive Bridge Cement | Unknown | Vivadent |
510(k) Summary
Product Description:
PermaCem:
PermaCem is a chemical-curing, radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:
- . Luting of orthodontic anchors and brackets
- . Luting of abutments to dentures
- . Core build-up material
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
- . Repair material for provisionals
- . Bite registration material
- . Build up material for plastic bite rails (occlusal individualisation).
PermaCem Dual:
PermaCem Dual is a dual cure (chemical and/or light cure), radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of
1
metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:
- Core build-up material .
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
- Repair material for provisionals .
- Bite registration material ●
- Build up material for plastic bite rails (occlusal individualisation). .
Indications for Use:
PermaCem is a chemical cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.
PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.
PermaCem and PermaCem Dual can also be used for:
- . Luting of orthodontic anchors and brackets
- Luting of abutments for dentures .
- Core build-up
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
- Repair material for resin-based provisionals
- . Bite registration material
- . Occlusal individualisation of plastic bite rails
Safety and Performance:
This submission is an 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), DMG USA, Inc. has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.
Conclusion:
Based on their indications for use, technological characteristics, and comparison to predicate devices, the PermaCem / PermaCem Dual materials have been shown to be safe and effective for their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which are meant to represent a stylized caduceus, a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2001
Ms. Pamela Papineau Consultant DMG USA, Incorporated 414 South State Street Dover, Delaware 19901
Re : K012316 Trade/Device Name: Permacem/Permacem Dual Requlation Number: 872.3275 Regulatory Class: II Product Code: EMA Dated: June 22, 2001 Received: July 23, 2001
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
3
Page 2 - Ms. Papineau
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ente feed 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.
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DMG USA Inc. Abbreviated 510(k) Premarket Notification
0000
PermaCem / PermaCem |
Page 1
510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: PermaCem / PermaCem Dual
Indications for Use:
PermaCem is a chemical cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.
PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.
PermaCem Dual can also be used for:
- Luting of orthodontic anchors and brackets .
- Luting of abutments for dentures ●
- Core build-up .
- Splinting of teeth in combination with wires, Kevlar or Ribbond-type . materials
- Repair material for resin-based provisionals .
- . Bite registration material
- Occlusal individualisation of plastic bite rails .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
(Per 21 CFR 801.109)
OR Over-the Counter Use __
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number __ K012316