(215 days)
Not Found
No
The device description and intended use focus on the material composition and physical properties of a bone graft substitute. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is indicated for filling and augmenting dental intraosseous, oral, and maxillofacial defects, and provides a bone void filler that resorbs and is replaced with bone during the healing process, which directly addresses a medical condition.
No
The device is a bone graft substitute, indicated for filling bony voids or gaps. Its function is to resorb and be replaced by bone during healing, rather than to diagnose medical conditions or diseases.
No
The device description clearly states it is a "synthetic resorbable osteoconductive bone graft substitute composed of a calcium phospho-silicate material and a calcium sulfate binder," 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:
- Intended Use: The intended use clearly states that the device is a "Settable Bone Graft Substitute" for filling bony voids and defects in dental, oral, and maxillofacial areas. It is used in vivo (within the body) to promote bone healing.
- Device Description: The description details the composition and mechanism of action as a bone graft substitute that is implanted and resorbed by the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo as a therapeutic implant.
N/A
Intended Use / Indications for Use
PerioGlas Plus - Settable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PerioGlas Plus is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); craniofacial augmentation; sinus lifts; cystic defects. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
PerioGlas Plus is a synthetic resorbable osteoconductive bone graft substitute composed of a calcium phospho-silicate material and a calcium sulfate binder. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. The inorganic calcium and phosphorous components are thermally incorporated in a sodium silicate network (PerioGlas) designed specifically for its absorbability and osteoconductive nature. The calcium sulfate component binds the PerioGlas particles together at the time of implantation and is absorbed from the graft site over the first several weeks following implantation. On absorption of the calcium sulfate, the PerioGlas particles remain in the graft site and are progressively aborbed and replaced by host bone during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraosseous, oral, and maxillofacial defects, bony voids or gaps, periodontal/infrabony defects, alveolar ridge, craniofacial, sinus lifts, cystic defects.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians familiar with bone grafting and internal/external fixation techniques
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)
In vitro data on the dissolution properties of the device calcium sulfate binder are presented. Characterization data on the residual particulate after dissolution of the calcium sulfate binder also is provided. Prior in vivo performance data for the device components are summarized.
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.
K992416, K962492, K930115, K955096
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.
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