FineEtch
FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Spident Co., Ltd., South Korea |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2026-04-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SPIDENT FINE ETCH 37 – 1.2 4ea | 4 | In distribution | |
| SPIDENT FINE ETCH 37 – 1.2 20ea | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Peak Universal Bond | Ultradent Products Inc. | 16 |
| Brush&Bond® | Parkell, Inc. | 16 |
| All-Bond 2 | Bisco, Inc. | 15 |
| The Orthodontic Store | Young Innovations Inc. | 15 |
| All-Bond 3 | Bisco, Inc. | 13 |
| Scotchbond™ Universal | 3M Deutschland GmbH | 13 |
| Select HV Etch w/BAC | Bisco, Inc. | 12 |
| Prelude | Danville Materials, LLC | 12 |
| Jade | Dharma Research, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242675 | 2024-11-01 |
| K241445 | 2024-07-22 |
| K120767 | 2012-05-24 |
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.