Renu Gel
CYTOPHIL, INC.
Cytophil, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007225376 | 3007225376 | Cytophil, Inc | 1 | N | 2026-01-01 | 2485 Corporate Circle, Unit 2 East Troy WI US 53120 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 88291 | 2010181453 | K161568 | Bone Solutions Mixing and Delivery System | FMF | 2016-09-16 |
| 88291 | 1101905703 | K150400 | Renu Gel | MIX | 2015-04-06 |
| 88291 | 1339054987 | K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | MIX | 2013-02-22 |
| 88291 | 1684926662 | K102937 | OSTEOPHIL BETA-TCP | MQV | 2010-12-27 |
| 88291 | 1904617969 | K093871 | PERIOPHIL B-TCP | LYC | 2010-04-22 |
| 88291 | 1031088769 | ||||
| 88291 | 1103484283 | ||||
| 88291 | 1419311243 | ||||
| 88291 | 1567329046 | ||||
| 88291 | 2027236221 |
Product Codes Associated With Registrations#
PMN#
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
CYTOPHIL INC
OSTEOPHIL BETA-TCP
CYTOPHIL INC
PERIOPHIL B-TCP
CYTOPHIL INC
PERIOPHIL BIPHASIC
CYTOPHIL INC
VOCALIS GEL
CYTOPHIL INC
VOCALIS AND VOCALIS SM
CYTOPHIL INC
CYTOPHIL TISSUE MARKER
CYTOPHIL INC
GUDID#
Regento Regenerative Scaffold - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Trab-X SB Synthetic Bone Matrix - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Callisto Granules Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Zavation ZV Graft Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Zavation ZV Graft Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
RegenOsteo Orthopedic Beta-TCP - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
RegenOsteo Orthopedic Beta-TCP - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Trab-X SB Synthetic Bone Matrix - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Trab-X SB Synthetic Bone Matrix - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Callisto Granules Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Callisto Granules Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Callisto Granules Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
RegenPerio Dental Beta-TCP - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Osteo-i Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Osteo-i Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Osteo-i Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules - Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30
Renú Gel - Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.
2019-10-30
Renú Transoral Needle - Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use.
2019-10-30
Renú Voice - Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.
2019-10-30
Bio TCP Beta-Tricalcium Phosphate Porous Granulate - Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2019-10-30