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Spirapost

FDA UDI

Class I (US FDA UDI)

by DMG America LLC

Identity

Trade Name
Spirapost FDA UDI
Generic Name
Root canal post kit FDA UDI
Device Name
Spirapost PFS Introductory Package (10 Tapered Posts, 10 Parallel Posts, 1 #4 Gates Glidden, 1 #5 Gates Glidden and 1 Spirapost Ruler) FDA UDI
Model / Reference
888100 FDA UDI
Description
Spirapost PFS Introductory Package (10 Tapered Posts, 10 Parallel Posts, 1 #4 Gates Glidden, 1 #5 Gates Glidden and 1 Spirapost Ruler) FDA UDI

Identifiers

Catalog Number
888100 FDA UDI
Primary DI / UDI-DI
D0338881001 FDA UDI
510(k) Number
K060075 FDA UDI
FDA Product Code
ELR FDA UDI
GMDN Term
Root canal post kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Root canal post kit

Spirapost by DMG America LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Root canal post kit.

Cleared under the same submission

K060075 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DMG America LLC

Sources (1)

  • FDA UDI d0eb8c51-da5e-45f7-911f-056812512634 36 fields · synced May 30, 2026