Identity
- Trade Name
- FineEtch FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- 37% Phosphoric Acid with semi-gel consistency for controlled contact. FDA UDI
- Model / Reference
- 101-1201 FDA UDI
- Description
- 37% Phosphoric Acid with semi-gel consistency for controlled contact. FDA UDI
Identifiers
- Catalog Number
- 101-1201 FDA UDI
- Primary DI / UDI-DI
- 08809262954036 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental etching solution
FineEtch by Spident Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (1)
- FDA UDI 7e991e25-4ea3-45a7-89c2-e539bb77777a 35 fields · synced Jun 7, 2026