Identity
- Trade Name
- Silane EUDAMEDFDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Silane EUDAMEDSilane Refill FDA UDI
- Model / Reference
- 410 EUDAMEDFDA UDI
- Description
- Silane Refill FDA UDI
Identifiers
- Catalog Number
- 410 FDA UDI
- Primary DI / UDI-DI
- 00883205103628 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF052Silane5S EUDAMED
- 510(k) Number
- K921409 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental etching solution
Silane by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI 14015159-e27c-4233-9a1e-833c964d3680 37 fields · synced Jun 18, 2026
- EUDAMED 92caf16f-1a20-4fb7-be3d-69f38376663d 61 fields · synced Jun 18, 2026