(300 days)
Cerasorb Dental (P800035)
Not Found
No
The summary describes a synthetic bone graft substitute and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a bone graft substitute used for filling and augmenting osseous defects, which falls under the category of a medical device but not specifically a therapeutic device that delivers therapy in the traditional sense (e.g., radiation therapy, drug delivery, electrical stimulation). It provides a scaffold for natural bone regeneration.
No
The device is a bone graft substitute used for filling and augmenting osseous defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "synthetic resorbable osteoconductive bone graft substitute composed of tricalcium phosphate," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description of calc-i-oss clearly states it is a synthetic resorbable osteoconductive bone graft substitute intended for filling and augmenting bone defects within the body (intraoral/maxillofacial). It is a material implanted or placed directly into the body to aid in bone regeneration.
- Lack of Diagnostic Function: The device does not perform any tests on samples from the body to provide diagnostic information. Its function is structural and regenerative.
Therefore, calc-i-oss falls under the category of a medical device, specifically a bone graft substitute, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
calc-i-oss is indicated for the filling and/or augmentation of intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Defects after removal of bone cysts, Periodontal defects in combination with membranes, I crodonal deleces in combination with autologous bone and membrane (Guided Bone Regeneration) Apicoectomy Extraction defects in combination with membranes Defects after surgical removal of retained teeth Sinus floor elevations Defects after removal of autologous bone
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
calc-i-oss is a synthetic resorbable osteoconductive bone graft substitute composed of tricalcium phosphate. The device is intended for dental intraosseous, oral, and cranio-/maxillofactial bony defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral/maxillofacial osseous defects
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): 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.
Cerasorb Dental (P800035)
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 and supports the conclusion of SE for calc-i-oss noted below.
Applicant's Name and Address: 1.
JUL 1 9 2005
| Ultradent Products, Inc. |
|---|
| -------------------------- |
| 505 West 10200 South |
|---|
| ---------------------- |
| South Jordan, Utah 84095 |
|---|
| -------------------------- |
| Telephone number: | 801-553-4200 |
|---|---|
| Fax number: | 801-572-0600 |
| Contact Person: | Tammy Lavery |
| RA/QA/QC Senior Manager |
Name of the Device: 2.
| Tradename: | calc-i-oss |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler and |
| Synthetic Resorbable Bone Graft Material | |
| Classification: | II (21CFR 872.3930) |
Legally Marketed Predicate Devices to which Equivalence is Claimed: 3.
Predicate Device Identified: Cerasorb Dental (P800035).
| calc-i-oss | Legally marketed Cerasorb (Dental) | |
|---|---|---|
| INDICATIONS: | Indicated for defects after removal of cysts, | |
| Augmentation of alveolar crest, possibly in | ||
| combination with autologous bone and | ||
| membrane (i.e. guided bond regeneration.) | ||
| Indicated for apicoectomy and extraction | ||
| defects in combination with membranes. | ||
| Indicated for filling of defects after surgical | ||
| removal of retained teeth Sinus floor | ||
| elevations and for defects after removal of | ||
| autologous bone. | Indicated for defects after removal of cysts; | |
| repair of marginal and periapical periodontal | ||
| alveolar bony pockets as well as bifurcations | ||
| and trifurcations of the teeth; augmentation of | ||
| the atrophied alveolar ridge; alveolar | ||
| augmentation of mandibular and maxillary | ||
| ridges; defects after apicoectomy; and filling | ||
| bone defects after surgical resection of impacted | ||
| teeth (without implantation). | ||
| CHEMICAL | ||
| COMPOSITION | ||
| & PURITY: | > 99% Phase-pure synthetic β-tricalcium | |
| phosphate. | > 99% Phase-pure synthetic β-tricalcium | |
| phosphate. | ||
| FORM: | High purity β-tricalcium phosphate porous | |
| spherical granules. | High purity β-tricalcium phosphate porous | |
| spherical granules. | ||
| PARTICLE SIZE | ||
| AND RANGE | ||
| (μm): | Granulate size range from 315 – 1600. | Granulate size range 500-1000. |
| POROSITY / | ||
| RESORPTION: | Interconnecting porous material 58% for high | |
| level of resorption. Refer to the enclosed | ||
| Solubility Report for more information on | ||
| porosity as well as resorption. | Interconnecting porous material 22% for high | |
| level of resorption. Refer to the enclosed | ||
| Solubility Report for more information on | ||
| porosity as well as resorption. |
Predicate Comparison Table
1
Device Description: 4.
calc-i-oss is a synthetic resorbable osteoconductive bone graft substitute composed of tricalcium phosphate. The device is intended for dental intraosseous, oral, and cranio-/maxillofactial bony defects.
5. Intended Use:
calc-i-oss is indicated for the filling and/or augmentation of intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Technological Characteristics: 6.
a. Chemical Composition:
calc-i-oss is a granulate consisting of bioresorbable, medical grade beta tricalcium phosphate and used for the filling of bone defects. (Refer to confidential test reports and data attached.)
b. Physical Properties:
calc-i-oss has a round macrostructure. Granulate sizes range between 315 and 1600 um. calc-i-oss is characterized by a porous and interconnecting microstructure. (Refer to confidential test reports and data attached.)
Risk Analysis and Test Methods: 7.
The risks noted below were identified and considered during the design of the product. Testing and/or actions were identified to mitigate each area of possible concern.
| Identified Risk | Mitigation |
|---|---|
| Ineffective Bone Formation | Material Characterization - See attached confidential test reports |
| and technical data of this submission. | |
| Adverse Tissue Reaction | See attached confidential test reports and technical data of this |
| submission. Note: β-TCP is known to be highly biocompatible, | |
| resorbable and osteoconductive. Numerous articles on safety and | |
| effectiveness are available concerning indications for use in | |
| dentistry and are noted in the literature. Mitigation concerning | |
| infection is also addressed below. | |
| Infection | Sterilization (SAL >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> note the regulation entitled, "Misorananing of 1915. Constitution on your responsibilities under the Part 807.97). You may other general international and Consumer Assistance at its |
| Act from the Division of Small Manufacturers, International and Consumer address Act from the Drvision of Billan I an (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html |
Sincerely yours,
Signature
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
5
INDICATIONS FOR USE
KO42583
510(k) Number (if known): Unknown
Device Name:
Indications For Use:
Defects after removal of bone cysts, Periodontal defects in combination with membranes, I crodonal deleces in combination with autologous bone and membrane (Guided Bone Regeneration) Apicoectomy Extraction defects in combination with membranes Defects after surgical removal of retained teeth Sinus floor elevations Defects after removal of autologous bone
X Prescription Use_ (Per 21 801 CFR Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Betz, DDS for Dr. Susan Remmer
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number
Page 1 of (Posted November 13, 200