Bone Molder - Straight

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Bone Molder - Straight FDA UDI
Generic Name: Osteotomy compression/distraction instrument FDA UDI
Device Name: Bone molder - used to compress bone in between dental Implants at time of placement FDA UDI
Model / Reference: Bone Molder - Straight FDA UDI
Description: Bone molder - used to compress bone in between dental Implants at time of placement FDA UDI

Identifiers

Catalog Number: Bone Molder - Straight FDA UDI
Primary DI / UDI-DI: 00083208130120 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Osteotomy compression/distraction instrument FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy compression/distraction instrument

Bone Molder - Straight by Suncoast Dental, Inc. — 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: Suncoast Dental, Inc.

Sources (1)

FDA UDI c24d112f-c0fd-499a-86ef-235719650aa8 35 fields · synced Jun 1, 2026