Roott

FDA UDI

Class II (US FDA UDI)

by Trate Llc

Identity

Trade Name: ROOTT FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Dental Implant, ROOTT R, D 5.5 mm, L 8 mm. FDA UDI
Model / Reference: R5508 FDA UDI
Description: Dental Implant, ROOTT R, D 5.5 mm, L 8 mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810149980589 FDA UDI
510(k) Number: K220022 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Roott by Trate Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
LW Solid Abutment — Ossvis Co., Ltd. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II

Cleared under the same submission

K220022 also covers:

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 II	Pending data

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

Manufacturer

Manufacturer: Trate Llc

Sources (1)

FDA UDI 5f55ec4d-20dd-47ed-9d60-64c1d25731b1 36 fields · synced Jun 8, 2026