FDA UDI In Commercial Distribution 🇺🇸 United States

Essentials by 3D Dental

DI: 00810126505675 · Model: HVE-B · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Essentials by 3D Dental
Primary DI
00810126505675
Version / Model
HVE-B
Company Name
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Labeler DUNS
080194935
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-05
Public Version
1
Public Version Date
2026-03-13
Public Version Status
New
Public Device Record Key
cb211d37-1f2d-41ac-a802-ccdf4327b408

Device Description

High-Volume Evacuator Tips 100/Pk

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EHZ Evacuator, Oral Cavity

GMDN Terms

Code Name
37434 Dental suction system cannula, single-use

Identifiers

Type ID
Primary 00810126505675