Amplifi
Long Term Membrane
2manufacturers in China registered for this device type
3catalogue numbers in this listing
10510(k) clearances naming this product code
7recalls on this code
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 | Collagen Matrix, Inc., United States |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2022-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMPLIFI-20X30 | 20mm x 30mm | In distribution |
| AMPLIFI-30X40 | 30mm x 40mm | In distribution |
| AMPLIFI-15X20 | 15mm x 20mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neocirrus | NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | 18 |
| 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 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233203 | 2024-05-01 |
| K142496 | 2014-11-24 |
| K141909 | 2014-11-05 |
| K110600 | 2011-07-29 |
| K100156 | 2010-08-11 |
| K090216 | 2009-09-18 |
| K062846 | 2006-10-13 |
| K062881 | 2006-10-11 |
| K011695 | 2001-08-07 |
| K003339 | 2001-01-08 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| 2019-03-19 | Class II | Under Investigation by firm | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box | 45 units -US;170 units OUS | 2020-05-12 |
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.