Identity
- Trade Name
- Best Etch FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- 37% Phosphoric Acid Etch designed to etch and prepare dentin and enamel. Unit dose includes (30) 0.6mL prefilled syringes & (30) 22ga Pre-bent tips. FDA UDI
- Model / Reference
- 502225 FDA UDI
- Description
- 37% Phosphoric Acid Etch designed to etch and prepare dentin and enamel. Unit dose includes (30) 0.6mL prefilled syringes & (30) 22ga Pre-bent tips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020151 FDA UDI
- 510(k) Number
- K984503 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
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 prosthesis priming agent
Best Etch by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis priming agent.
- ACRIFIX — DeltaMed GmbH · Class II
- HC PRIMER — SHOFU DENTAL CORP. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
- Mirage Silane Bond Enhancer — Chameleon Dental Products, Inc.
- 3Delta Denture Bond — DeltaMed GmbH · Class II
- CLEARFIL™ PORCELAIN BOND ACTIVATOR — KURARAY NORITAKE DENTAL INC. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
- Porcelain Primer — BISCO INC. · Class II
Cleared under the same submission
K984503 also covers:
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- Alpha-Bond® — Dental Technologies, Inc.
- Alpha-Bond® Activator — Dental Technologies, Inc.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vista Dental
Sources (1)
- FDA UDI 5cd58512-3063-468f-9936-0a9e7a2c0cc0 34 fields · synced May 30, 2026