FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTURE PLASTIC TEETH,76 ELM
K Number: K915276
·
Decision Feb 3, 1992
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
64
Review Days
70
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Basic Information
- Device Name
- DENTURE PLASTIC TEETH,76 ELM
- K Number
- K915276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nobelpharma USA, Inc.
- Date Received
- November 25, 1991
- Decision Date
- February 3, 1992
- Product Code
- ELM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
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Other Clearances by Nobelpharma USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Jun 28, 1999 | Substantially Equivalent |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Sep 6, 1996 | Substantially Equivalent |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Aug 9, 1996 | Substantially Equivalent |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Jul 22, 1996 | Substantially Equivalent |
| K961736 | 17 ANGULATED ABUTMENT | Jul 18, 1996 | Substantially Equivalent |
| K961737 | CERA ONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K960639 | ABUTMENT SELECTION KIT | May 14, 1996 | Substantially Equivalent |
| K955697 | ABUTMENT RETRIEVAL KIT | Jan 30, 1996 | Substantially Equivalent |
| K955372 | BALL ATTACHMENT SYSTEM | Jan 23, 1996 | Substantially Equivalent |