(50 days)
Not Found
No
The device description focuses on the material composition and physical properties of a synthetic bone graft substitute. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to augment and reconstruct bone defects, which directly addresses medical conditions and improves patient health outcomes. This aligns with the definition of a therapeutic device.
No
The device description and intended use clearly state that Cerasorb® products are sterile, synthetic, ceramic matrices used for bone regeneration and filling defects, which are therapeutic and reconstructive purposes, not diagnostic.
No
The device description clearly states that the device is a sterile, synthetic, ceramic matrix in granular or morsel form, indicating it is a physical material intended for implantation or filling bone defects, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a material for filling and augmenting bone defects in the oral and maxillofacial region. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details the physical and chemical properties of the material (synthetic ceramic matrix, Beta-Tricalcium Phosphate) and its function as an osteoconductive scaffold that is resorbed and replaced by bone. This aligns with a medical device used for tissue repair and regeneration, not for analyzing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.), detect analytes, or provide information for diagnosing a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cerasorb devices are used in vivo (inside the body) for surgical and reconstructive procedures.
N/A
Intended Use / Indications for Use
Cerasorb® M DENTAL is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of miracony person resection, apicoectorny, and cystectorny.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Elevation of periodontal defects in conjunction with products intended for Filling of perfodonali action (GTR) and Guided Bone Regeneration (GBR).
- Guided Tissue Regenciation (Oric) and Cattler with products intended for Guided Bone Regeneration (GBR).
Cerasorb® DENTAL is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge. -
- Filling of infrabony periodontal defects. ・
- Filling of defects after root resection, apicoectomy, and cystectomy. -
- Filling of extraction sockets to enhance preservation of the alveolar ridge. -
- Elevation of the maxillary sinus floor. -
- Filling of periodontal defects in conjunction with products intended for a Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Gulded I Issue Regenciation (OTT) ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -Guided Bone Regeneration (GBR).
Cerasorb® Perio is recommended for:
- Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets.
- Filling of bifurcations and trifurcations
Product codes (comma separated list FDA assigned to the subject device)
LYC
LPK
Device Description
Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, Cerasorb DENTRE, Ceramic matrix in either granilar form (Cerasorb Syntifetic, polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken DENTAL), polygonal "shaped" morbols" (Soint of pure-phase Beta-Tricalcium Phosphate grandlate (Crasorb Ferro). This access. ply with the ASTM F 1088-04. The devices, when with a phase purry of - 9778 and compy make of large, smoothly intercomected pores applied to a bony defect, ereate a rto DENTAL approx. 35%, Cerasorb M DENTAL providing anterent porosity] and Cerasorb Perio approx. 25vol%).
approx. 05 v0170 [total porochy] and ored by a validated manufacturing process which The different designs are managed and reproducibility. Due to their synthetic nature guarantees battli to batch conformily and repredactions and are neither locally nor systemically toxic.
In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone.
Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double Cerason DENTAL, Cetasons in gamma irradiation) and are for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, infrabony periodontal defects, defects after root resection, apicoectomy, cystectomy, extraction sockets, maxillary sinus floor, periodontal defects, single-or multi-wall bone pockets, bifurcations and trifurcations.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
PMA800035, K992416, K040278, K033815, K970321
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human figures, possibly symbolizing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2007
Curasan AG, Frankfurt Facility C/O Mr. Eric Weichert President Applications Specialist International, Incorporated 109 Shore Drive Garner, North Carolina 27529
Re: K051443
Trade/Device Name: Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 31, 2005 Received: June 2, 2005
Dear Mr. Weichert:
This letter corrects our substantially equivalent letter of August 3, 2005.
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 (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 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.
1
Page 2 - Mr. Weichert
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 (QS) 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 continue 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 (http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Liang Ph.D.
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
2
Cerasorb® M DENTAL
Indications for Use
KOSI443 510(k) Number (if known):
Cerasorb® M DENTAL Device Name:
Indications for Use:
Cerasorb® M DENTAL is recommended for:
-
Augmentation or reconstructive treatment of the alveolar ridge.
-
Filling of infrabony periodontal defects.
-
Filling of miracony person resection, apicoectorny, and cystectorny.
-
Filling of extraction sockets to enhance preservation of the alveolar ridge.
-
Elevation of the maxillary sinus floor.
-
Elevation of periodontal defects in conjunction with products intended for Filling of perfodonali action (GTR) and Guided Bone Regeneration (GBR).
-
Guided Tissue Regenciation (Oric) and Cattler with products intended for Guided Bone Regeneration (GBR).
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Robert DDS for Dr. Susan Rumner
(Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control. Dental De
510(k) Number:
Page 1 of 1_
3
Statements of Indications for Use 1.4
Cerasorb® DENTAL
Indications for Use
KOS 1443 510(k) Number (if known):
Cerasorb® DENTAL Device Name:
Indications for Use:
Cerasorb® DENTAL is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge. -
- Filling of infrabony periodontal defects. ・
- Filling of defects after root resection, apicoectomy, and cystectomy. -
- Filling of extraction sockets to enhance preservation of the alveolar ridge. -
- Elevation of the maxillary sinus floor. -
- Filling of periodontal defects in conjunction with products intended for a Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Gulded I Issue Regenciation (OTT) ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -Guided Bone Regeneration (GBR).
Prescription Use _
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) (Division Sign-Olif)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number:_
13 - 6
4
Cerasorb® Perio
Indications for Use
KOSIYYZ 510(k) Number (if known):
Cerasorb® Perio Device Name:
Indications for Use:
Cerasorb® Perio is recommended for:
- Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets.
- Filling of bifurcations and trifurcations
Prescription Use __
. AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
5
JUL 2 2 2 2005
Image /page/5/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are black and appear to be slightly distorted, giving them a rounded, almost cartoonish look. The word is presented in a single line, with each letter connected to the next.
Abbreviated 510 (k) Summary:
Cerasorb® DENTAL Cerasorb® M DENTAL Cerasorb® Perio
SUBMISSION INFORMATION 1.
| Name and Address of the Sponsor: | curasan AG
Lindigstrasse 4
63801 Kleinostheim
Germany |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Wolf-Dietrich Huebner, MD
Medical Director
Tel.: +49 – 6027 – 4686-325
Fax: +49 – 6027 – 4686-433
E – Mail: wolf.huebner@curasan.de |
| Registered U. S. Agent: | Dr. Eric Wiechert, Ph.D.
109 Shore Drive
Garner, NC 27529, USA
Phone: 919 – 772-8518, fax: 919 – 772-1300
E – Mail: ewiecher@bellsouth.net |
DEVICE IDENTIFICATION 2.
| Proprietary Name: | Cerasorb® DENTAL
Cerasorb® M DENTAL
Cerasorb® Perio |
|-----------------------------------|--------------------------------------------------------------|
| Common Name: | Bone Void Filler, Synthetic |
| Classification Name : | Bone Grafting Material, Synthetic |
| Classification: | Class II, Special Controls |
| Classification regulation Number: | 21CFR 872.3930 |
| Product Code: | LPK, Tricalcium Phosphate Granules for Dental
Bone Repair |
6
PREDICATE DEVICES 3.
Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 FENOGILS . RO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321
INTENDED USE 4.
Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for :
- Augmentation or reconstructive treatment of the alveolar ridge -
- Filling of infrabony periodontal defects -
- Filling of defects after root resection, apicoectomy, and cystectomy. -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of the maxillary sinus floor -
- Eievaton of the maxmaly since new
Filling of periodontal defects in conjunction with products intended for Guided -Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filside Regeneration (Cris) ats in conjunction with products intended for Guided -Bone Regeneration (GBR)
Cerasorb® Perio is recommended for:
- Filling and/or reconstruction of non-infected periodontal bone defects in Filling and/or "reconstration" other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets
- Filling of bifurcations and trifurcations
DESCRIPTION OF THE DEVICE 5.
Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, Cerasorb DENTRE, Ceramic matrix in either granilar form (Cerasorb Syntifetic, polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken DENTAL), polygonal "shaped" morbols" (Soint of pure-phase Beta-Tricalcium Phosphate grandlate (Crasorb Ferro). This access. ply with the ASTM F 1088-04. The devices, when with a phase purry of - 9778 and compy make of large, smoothly intercomected pores applied to a bony defect, ereate a rto DENTAL approx. 35%, Cerasorb M DENTAL providing anterent porosity] and Cerasorb Perio approx. 25vol%).
approx. 05 v0170 [total porochy] and ored by a validated manufacturing process which The different designs are managed and reproducibility. Due to their synthetic nature guarantees battli to batch conformily and repredactions and are neither locally nor systemically toxic.
Iocally not systembally toxic.
In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone.
7
Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double Cerason DENTAL, Cetasons in gamma irradiation) and are for single-use only.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are substantially Celasolo DENTAL; Colusion -11- narketed and approved/cleared bone void fillers for defects in the oral/maxillofacial and dental region, such as Cerasorb DENTAL (the sponsors own device formally regulated as a PMA, PMA800035), BIO-OSS® Anorganic sponsors own device formally regulated as a Flass (K992416, K040278).
Bovine Dolle (1376521, 1635013) and ifferent (Beta-Tricalcium Phosphate vs. Bovine Although the source of the material), the intended use, recommended indications Bone vs. synthette blouerry glass material site, and performance data fr the three Cerasorb for use, and the predicate devices are essentially similar. Also, all materials are designs and biocompatible. In contact with vital bone any of the bone grafting materials is resorbed and gradually replaced by new bone.
materials is resorded and gradually replasse of nones the effectiveness and safety of the Cerasorb designs compared to the predicate devices.
STATEMENT OF TECHNOLOGICAL COMPARISON 7.
All Cerasorb design modifications consist of pure phase Beta-Tricalcium Phosphate All Cerason design modified on the 1088-04. The material is of intercomnecting porosity, osteoconductive and resorbable.