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INNO SLA Submerged Implant System-Impression Coping

FDA UDI

Class II (US FDA UDI)

by Cowellmedi Co., Ltd

Identity

Trade Name
INNO SLA Submerged Implant System-Impression Coping FDA UDI
Generic Name
Dental precision attachment simulator/analog, single-use FDA UDI
Model / Reference
SINR001 FDA UDI

Identifiers

Primary DI / UDI-DI
08809471723621 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental precision attachment simulator/analog, single-use 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

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental precision attachment simulator/analog, single-use

INNO SLA Submerged Implant System-Impression Coping by Cowellmedi Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental precision attachment simulator/analog, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cowellmedi Co., Ltd

Sources (1)

  • FDA UDI f58a2025-4937-4ac6-846e-a101424e0ce9 32 fields · synced Jun 1, 2026