Calamus

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Calamus FDA UDI
Generic Name: Dental laboratory drilling system handpiece FDA UDI
Device Name: Pack Handpiece For Dual FDA UDI
Model / Reference: PACKHAND FDA UDI
Description: Pack Handpiece For Dual FDA UDI

Identifiers

Catalog Number: PACKHAND FDA UDI
Primary DI / UDI-DI: D716PACKHAND1 FDA UDI
FDA Product Code: EKM FDA UDI
GMDN Term: Dental laboratory drilling system handpiece FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental laboratory drilling system handpiece

Calamus by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental laboratory drilling system handpiece.

LHP-6/L5M/MCC6 assy. — OSADA ELECTRIC CO., LTD. · Class I
Maxso S20A-IS — Beyes Dental Canada Inc · Class I
Maxso S20A-IS/E6 — Beyes Dental Canada Inc · Class I
LHP-12 handpiece — OSADA ELECTRIC CO., LTD. · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
Maxso X99L — Beyes Dental Canada Inc · Class I
LHP-12/L12M/MC12 — OSADA ELECTRIC CO., LTD. · Class I
LHP-6 handpiece — OSADA ELECTRIC CO., LTD. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Tulsa Dental Products Llc

Sources (1)

FDA UDI 5ad4eec9-60cd-42bc-a5f6-e713bc01babc 34 fields · synced May 29, 2026