(318 days)
Not Found
No
The device description focuses on the material properties and physical form of a synthetic bone graft substitute. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is used for augmentation, reconstructive treatment, and filling of various defects in bone and soft tissue, which directly treats or remediates a disease or injury.
No
The device description and intended use indicate that CERASORB® products are ceramic matrices used for bone augmentation and reconstruction, which are therapeutic rather than diagnostic purposes.
No
The device description clearly states that the device is a "sterile, synthetic, porous and biocompatible ceramic matrix in either granular form, polygonal shaped morsels or polygonal broken granulate." This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone augmentation and reconstruction in the oral cavity. These are therapeutic interventions performed directly on the patient's body.
- Device Description: The device is described as a sterile, synthetic, porous ceramic matrix intended to be implanted into bone defects. This is a medical device used for treatment, not for analyzing samples from the body to diagnose or monitor a condition.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
CERASORB® CLASSIC and CERASORB® M 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
-Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
-Filling of perio-implant defects 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 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
Device Description
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%).
The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.
In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via 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, perio-implant defects, non-infected periodontal bone defects, single- or multi-wall bone pockets, bifurcations and trifurcations
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.
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
510(k) Summary
Section 05 Erst
Arzneimittel AG
Special 510 (k) Summary: CERASORB® CLASSIC CERASORB® M CERASORB® Perio
SEP
2 0 2012
Date prepared: September 17, 2012
l. SUBMISSION INFORMATION
| Name and Address
of the Sponsor: | Riemser Arzneimittel AG
An der Wick 7
Greifswald-Insel Riems
Mecklenburg-Vorpommern 17493, Germany |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Andreas Püttner
Head of Regulatory Affairs
Tel.: +49-3835-1760
Fax: +49-3835-176778
E - Mail: dr.puettner@riemser.de |
| Registered U. S. Agent: | James M. Clinton
Quality & Regulatory Consulting, LLC
5105 Fairoaks Rd
Durham, NC 27712, USA
Phone: +1919-247-0479, fax: +1919-287-2551
E - Mail: clintonjm@earthlink.net |
| 2. DEVICE IDENTIFICATION | |
| Proprietary Name: | CERASORB® CLASSIC
CERASORB® M
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: LYC
1
510(k) Summary
Section 05
3. PREDICATE DEVICES
CERASORB® DENTAL: K051443 CERASORB® M DENTAL: K051443 CERASORB® Perio: K051443
4. INTENDED USE
CERASORB® CLASSIC and CERASORB® M 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
-Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
-Filling of perio-implant defects 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 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
DESCRIPTION OF THE DEVICE 5.
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%).
The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.
In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.
2
| CERASORB ® | Section 05 |
|---|---|
| 510(k) Summary | RIEMSER Arzneimittel AG |
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio differ from the products of the same name cleared by K051443 only in the information on the labeling designating the manufacturer. Riemser AG is now both the manufacturer and distributor of the CERASORB® products described in the present 510(k) document.
STATEMENT OF TECHNOLOGICAL COMPARISON 7.
The CERASORB® CLASSIC, CERASORB® M, and CERASORB® Perio devices are substantially equivalent to the respective devices cleared by K051443: CERASORB® DENTAL, CERASORB® M Dental, and CERASORB® Perio.
5 - 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three overlapping, curved lines forming its body and wings, conveying a sense of motion and progress. The overall design is simple, yet recognizable, representing the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 0 2012
Riemser Arzneimittel AG C/O Mr. James M. Clinton Quality & Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road Durham, North Carolina 27712
Re: K113282
Trade/Device Name: Cerasorb® Classic Cerasorb® M Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 17, 2012 Received: August 21, 2012
Dear Mr. Clinton:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2- Mr. Clinton
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
Page 1 of l
Page 1 of __
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kummer
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Anest. Dental Devices
510(k) Number: K113252
4 - 1
Indications for Use
KI13282 510(k) Number (if known):
Cerasorb® CLASSIC Device Name:
Indications for Use:
Cerasorb® CLASSIC is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge. -
- ー 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 Guided -Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of perio-implant defects in conjunction with products intended for Guided -Bone Regeneration (GBR).
Prescription Use (Part 21 CFR 801 Subpart D)
IF NEEDED)
AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Over-The-Counter Use (21 CFR 807 Subpart C)
Section 04
(k) Number (if known): K 1 328
Cerasorb® CLASSIC
6
| CERASORB® |
|---|
| ----------- |
Indications for Use
Indications for Use
510(k) Number (if known):
Cerasorb® M Device Name:
Indications for Use:
Cerasorb® M 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 Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Prescription Use (Part 21 CFR 801 Subpart D)
:: '' '
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Section 04
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Page 1 of | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K113282 |
4 - 2
7
Indications for Use
Image /page/7/Picture/2 description: The image shows the text "K113282" at the top, followed by "Section 04" in bold. The text "Section 04" is centered and has a line above it. Below that is a logo that is difficult to make out.
A. 2022年12月16日
Indications for Use
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 > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Sian-Off) Division of Anesthesiology, General Hosanal Infection Control, Dental Devices
Page 1 of
510(k) Number: K152858
4 - 3