(77 days)
Antical Contract
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No
The summary describes a kit of dental materials for cementing an endodontic post, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is a kit containing dental materials for cementing an endodontic post; it does not directly treat or prevent a disease, but rather facilitates a dental restorative procedure.
No
This device is a kit of dental materials used for preparing the root canal and cementing an endodontic post, which is a treatment procedure rather than a diagnostic one.
No
The device description clearly lists physical components such as syringes, bottles of solutions, plastic wells, mixing paper, mixing sticks, and applicator tips, indicating it is a kit of physical materials, 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 prepare the root canal and cement an endodontic post. This is a procedure performed in vivo (within the patient's body), not in vitro (outside the body, typically on biological samples).
- Device Description: The components are materials used directly in the root canal during a dental procedure. They are not designed to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Pulpdent ENDODONTIC POST CEMENT KIT is a dental device used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent ENDODONTIC POST CEMENT KIT is a convenience package of dental materials used by the dentist to prepare the root canal and cement an endodontic post into the canal prior to core build up.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The kit contains one 4.5 gram syringe each of resin cement base and catalyst, one 10 ml bottle of bonding agent, 34 ml each of 17 % EDTA solution and 5.25 % sodium hypochlorite solution, plastic wells, mixing paper, mixing sticks and applicator tips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
root canal
Indicated Patient Age Range
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Intended User / Care Setting
dentist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Antical Contract
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.
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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).
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§ 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
SEP 30 1988
EXHIBIT 7
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA.
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262
PULPDENT ENDODONTIC POST CEMENT KIT DEVICE NAME:
PREDICATE DEVICES:
Antical Contract
DESCRIPTION AND INTENDED USE:
Pulpdent ENDODONTIC POST CEMENT KIT is a convenience package of dental materials used by the dentist to prepare the root canal and cement an endodontic post into the canal prior to core build up. The kit contains one 4.5 gram syringe each of resin cement base and catalyst, one 10 ml bottle of bonding agent, 34 ml each of 17 % EDTA solution and 5.25 % sodium hypochlorite solution, plastic wells, mixing paper, mixing sticks and applicator tips.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent ENDODONTIC POST CEMENT KIT is substantially equivalent in composition and intended use as the predicate products. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS:
According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... composites... are relatively trouble free. There is no evidence of short or long term risk ... there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.
The American Dental Association Council on Dental Therapeutics in their publication, Accepted Dental Therapeutics, considers both EDTA and sodium hypochlorite safe and effective aids in preparing a root canal for further procedures. Please see EXHIBIT 6 for the entire citations.