Device
TBS BASICS Boley Gauge, 145mm
Manufacturer
ACME ENTERPRISE.
Model: TBSB426 Catalog: TBSB426 DI: G149TBSB4260 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 Boley Gauge, 145mm
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: f31f18e5-2388-423c-840f-5c0ceaa6a522
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: G149TBSB4260
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 31846
Name: Dental implantation depth/angle gauge, reusable
Definition:
A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.
FDA Product Codes
EIL
Gauge, Depth, Instrument, Dental