Device
TBS BASICS 12 Novatech Cement Remover, #9 Hollow Handle
Manufacturer
ACME ENTERPRISE.
ACME ENTERPRISE.
Model: TBSB428
Catalog: TBSB428
DI: G149TBSB4280
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
TBS BASICS 12 Novatech Cement Remover, #9 Hollow Handle
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eb9ad817-6721-4d9e-8edb-b130306e77e4
Distribution Status:
In Commercial Distribution
DUNS Number:
645459892
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G149TBSB4280
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 35320
Name: Manual dental scaler, reusable
Definition:
A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.
FDA Product Codes
EKH
Carver, Dental Amalgam, Operative