FDA UDI Not in Commercial Distribution 🇺🇸 United States

ETCH-ALL™ Dental Etching Gel

DI: D701EA62 · Model: EA6 · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ETCH-ALL™ Dental Etching Gel
Primary DI
D701EA62
Version / Model
EA6
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-28
Public Version
4
Public Version Date
2025-10-09
Public Version Status
Update
Public Device Record Key
5c2efb47-c58d-46e5-b23b-41574d1ca377
Distribution End Date
2016-11-01

Device Description

6 mL syringe 10% Phosphoric Acid

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBF Material, Tooth Shade, Resin

GMDN Terms

Code Name
36153 Dental tooth-etching solution

Identifiers

Type ID
Primary D701EA62

Device Sizes

Type Value Unit Text
Total Volume 6 Milliliter