Tatum Surgical/Abutment (Post)

FDA UDI

Class II (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Tatum Surgical/Abutment (Post) FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Implant Abutment 3.5mm x 0 degree (Straight)Push-In Post -9mm Height FDA UDI
Model / Reference: Abutment/3.5 x 0 degree Push-In Post FDA UDI
Description: Implant Abutment 3.5mm x 0 degree (Straight)Push-In Post -9mm Height FDA UDI

Identifiers

Catalog Number: PN35.00P FDA UDI
Primary DI / UDI-DI: 00083208735097 FDA UDI
510(k) Number: K811923 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

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

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 9 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Tatum Surgical/Abutment (Post) by Suncoast Dental, Inc. — 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

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

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Manufacturer

Manufacturer: Suncoast Dental, Inc.

Sources (1)

FDA UDI ff256f85-1f83-4e02-93f3-a6746d040e58 37 fields · synced Jun 8, 2026