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Countersink Drill

FDA UDI

Class I (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name
COUNTERSINK DRILL FDA UDI
Generic Name
Dental implant/prosthesis surgical procedure kit FDA UDI
Device Name
COUNTERSINK DRILL PREMIUM, D. 3.80 MM FDA UDI
Model / Reference
A-FCC-380 FDA UDI
Description
COUNTERSINK DRILL PREMIUM, D. 3.80 MM FDA UDI

Identifiers

Catalog Number
A-FCC-380 FDA UDI
Primary DI / UDI-DI
D7701354963 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant/prosthesis surgical procedure kit 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant/prosthesis surgical procedure kit

Countersink Drill by Sweden & Martina Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant/prosthesis surgical procedure kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sweden & Martina Inc

Sources (1)

  • FDA UDI 47e9b1fc-52d4-4c89-88d3-1bbd70c9d1f0 35 fields · synced Jun 1, 2026