Cerasorb M Dental

FDA UDI

Class II (US FDA UDI)

by curasan AG

Identity

Trade Name: Cerasorb M Dental FDA UDI
Generic Name: Dental bone matrix implant, synthetic FDA UDI
Device Name: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M 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 Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) FDA UDI
Model / Reference: 500-1000µm FDA UDI
Description: Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M 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 Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) FDA UDI

Identifiers

Catalog Number: 5 x 1.0 cc FDA UDI
Primary DI / UDI-DI: ECURS10M0500 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Dental bone matrix implant, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.0 Centiliter FDA UDI

Category: Dental bone matrix implant, synthetic

Cerasorb M Dental by curasan AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: curasan AG

Sources (1)

FDA UDI 92616f18-ae12-4a68-9116-398c22fb11de 36 fields · synced Jun 8, 2026