Blockout Spacers (10)

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: Blockout Spacers (10) FDA UDI
Generic Name: Dental impression spacer FDA UDI
Device Name: Provides relief space for adhesive material and prevent overflow of cement into function areas of the attachment when connecting elements of implant attachment components. Made from silicone rubber. FDA UDI
Model / Reference: 909013 FDA UDI
Description: Provides relief space for adhesive material and prevent overflow of cement into function areas of the attachment when connecting elements of implant attachment components. Made from silicone rubber. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549118197 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental impression spacer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental impression spacer

Blockout Spacers (10) by Sterngold Dental LLC — 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: Sterngold Dental LLC

Sources (1)

FDA UDI 0aa405c4-54ed-426e-b73d-9aa9e2815a50 34 fields · synced May 31, 2026