Neocirrus
18 catalogue numbers from AGM-E-010040, listed by NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd., China, under Barrier, Animal Source, Intraoral. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd., China |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Establishment | Manufacturer |
| 510(k) | K250512 |
| Record published | 2026-04-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AGM-E-010040 | In distribution | |
| AGM-R-010010 | In distribution | |
| AGM-E-010030 | In distribution | |
| AGM-E-010020 | In distribution | |
| AGM-R-020020 | In distribution | |
| AGM-E-020030 | In distribution | |
| AGM-E-020040 | In distribution | |
| AGM-R-010040 | In distribution | |
| AGM-R-030030 | In distribution | |
| AGM-R-020030 | In distribution | |
| AGM-R-020040 | In distribution | |
| AGM-E-030030 | In distribution | |
| AGM-R-030040 | In distribution | |
| AGM-E-010010 | In distribution | |
| AGM-R-010030 | In distribution | |
| AGM-E-030040 | In distribution | |
| AGM-E-020020 | In distribution | |
| AGM-R-010020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gibson Healthcare | Benco Dental Supply Co. | 18 |
| Endoform™ Dental Membrane | Aroa Biosurgery Ltd | 12 |
| Ousia bioADAPT | Ace Surgical Supply Co., Inc. | 9 |
| GuidOss | Nibec Co Ltd | 9 |
| RCM6 Resorbable Collagen Membrane | Ace Surgical Supply Co., Inc. | 9 |
| Ousia bioMAINTAIN | Ace Surgical Supply Co., Inc. | 9 |
| Genoss Collagen Membrane | Genoss Co., Ltd. | 9 |
| bioMAINTAIN | Collagen Matrix, Inc. | 9 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 8 |
| THE Cover | Purgo Biologics Inc. | 8 |
| PerioMatrix | Collagen Matrix, Inc. | 7 |
| AmpliDerm | Collagen Matrix, Inc. | 7 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250512 | 2025-12-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.