Identity
- Trade Name
- Ena Etch ® FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Name: ETCHING GEL Model: 37% EUDAMEDENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 ENA-ETCH Etching gel 37% 2 ml FDA UDI
- Model / Reference
- COSM101 EUDAMEDFDA UDI
- Description
- ENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 ENA-ETCH Etching gel 37% 2 ml FDA UDI
Identifiers
- Catalog Number
- COSM101 FDA UDI
- Primary DI / UDI-DI
- EMICCOSM1011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1ACID74 EUDAMED
- 510(k) Number
- K072978 FDA UDI
- FDA Product Code
- DYH 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
- 872.3750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Dental etching solution
Ena Etch ® by Micerium Spa — 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
Cleared under the same submission
K072978 also covers:
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 3019f426-20bb-40e8-b8f0-1891c36fad64 37 fields · synced Jun 18, 2026
- EUDAMED 9fece6da-cae2-460a-8996-fc1927ee1642 61 fields · synced Jun 18, 2026