Model: 1003665
DI: 00348783005875
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
PERIOTOME TB-POSTERIOR
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:
62051b6e-60d7-45f8-953f-a8734191cc42
Distribution Status:
In Commercial Distribution
DUNS Number:
014789663
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00348783005875
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45713
Name: Periotome, reusable
Definition:
A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a reusable device.
FDA Product Codes
DZN
Instruments, Dental Hand