Helix Classic Reamers

FDA UDI

Class I (US FDA UDI)

by Dentatus AB

Identity

Trade Name: Helix Classic Reamers FDA UDI
Generic Name: Pin/post dental drill bit FDA UDI
Device Name: 3x Helix Classic Reamers for #6 Posts - 1.80 Short FDA UDI
Model / Reference: RSA-6/3 FDA UDI
Description: 3x Helix Classic Reamers for #6 Posts - 1.80 Short FDA UDI

Identifiers

Catalog Number: RSA-6/3 FDA UDI
Primary DI / UDI-DI: 07350081491949 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Pin/post dental drill bit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 1.80 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI

Category: Pin/post dental drill bit

Helix Classic Reamers by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Dentatus AB

Sources (1)

FDA UDI 827ec2f7-d9ab-4410-898c-a971a092df54 35 fields · synced May 30, 2026