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Mis

FDA UDI

Class II (US FDA UDI)

by MIS Implants Technologies Ltd.

Identity

Trade Name
MIS FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
Healing cap Ø4.8x4mm coni. con., SP FDA UDI
Model / Reference
CS-HS448 FDA UDI
Description
Healing cap Ø4.8x4mm coni. con., SP FDA UDI

Identifiers

Primary DI / UDI-DI
07290108996654 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, temporary, preformed, 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-use

MIS is a prefabricated dental implant support system designed to provide temporary intermediate fixation levels between dental implants and temporary restorations during the oral soft-tissue healing and sculpturing period. This single-use device typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in various shapes, sizes, and materials.

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MIS Implants Technologies Ltd.

Sources (1)

  • FDA UDI 4b130b64-1d42-4988-a73f-12be3b7d3dd7 33 fields · synced Jul 26, 2026