Device
Evogue Dental Unit CART DELIVERY SYSTEM WITH VACUUM
Manufacturer
TAKARA BELMONT CORP.
TAKARA BELMONT CORP.
Model: AU-HV3610
Catalog: AU-HV3610
DI: 04952195483259
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Evogue Dental Unit CART DELIVERY SYSTEM WITH VACUUM
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6bddaf47-b897-4795-919a-7875db340000
Distribution Status:
In Commercial Distribution
DUNS Number:
690540349
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04952195483259
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34991
Name: Dental delivery system
Definition:
A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.
FDA Product Codes
EIA
Unit, Operative Dental
Premarket Submissions
Submission Number:
K152100
Supplement Number:
000